ke !
Ta ne
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P RO STAT E C A NC E R C OM M U N IC AT ION
VOLUME 28, NUMBER 2 • JUNE, 2012
FOUNDER: LLOYD J. NEY, SR. – FOUNDED 1984
In This Issue:
Intimacy After Prostate Cancer
Optimizing Outcomes Of
Advanced Prostate Cancer
What The Heck Has Been
Going On In My World
Staying Active With
Urinary Incontinence
Be sure to visit our new website at: www.paactusa.org
We now offer the convenience of making donations online!
Life Without Prostate Cancer:
Imagine The Possibilities!
P A A C T,
I N C.
Published Quarterly by: PAACT, Inc.
Patient Advocates for Advanced Cancer Treatments
1143 Parmelee NW
Grand Rapids, MI 49504
President…Richard H. Profit Jr.
Editors….Richard H. Profit Jr./Molly Meyers
Staff….Molly Meyers/Jill Beckwith
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Prostate Cancer Communication
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Articles authored by other than the editor may not fully reflect the views
of the corporation but are printed with the understanding that the patient
has the right to make his own interpretation of the efficacy of the information provided.
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omitted. If you would like to obtain those references, please contact PAACT,
we keep all of the original articles and the references used on file.
President and Chairperson:
Medical Advisory Board:
Richard H. Profit, Jr.
Board of Directors:
Richard J. Ablin, Ph.D.
V. Elayne Arterbery, M.D.
Robert A. Badalament, M.D.
Duke K. Bahn, M.D.
Israel Barken, M.D.
E. Roy Berger, M.D., F.A.C.P.
Douglas O. Chinn, M.D.
Michael J. Dattoli, M.D.
Fernand Labrie, M.D.
Gary E. Leach, M.D.
Fred Lee, Sr., M.D.
Robert Leibowitz, M.D.
Mark A. Moyad, M.D., M.P.H.
Charles E. Myers, Jr., M.D.
Haakon Ragde, M.D.
Oliver Sartor, M.D.
Stephen B. Strum, M.D., F.A.C.P.
Ashutosh (Ash) K. Tewari, M.D., M.CH.
Donald L. Trump, M.D.
Newton Dilley
Saleem Durvesh, Executive
Marketing Director
Edwin Kuberski, Treasurer
Helen Mellema
Janet Ney, Director
Janette Ney, Director
Anthony Staicer, Director
Honorary Board Members:
A.W. (Bud) Irish
Russell Osbun
Art Schlefstein
contact us
PAACT MEMBERS and non-members
may contact PAACT headquarters directly (616-453-1477) to speak with our
counselor (Richard H Profit, Jr.) for a free
unlimited medical consultation regarding DIAGNOSIS, EVALUATION, DETECTION
AND TREATMENT options for prostate
cancer. Mr. Profit has worked with doctors in all aspects of prostate cancer
treatment for over 13 years.
TABLE OF CONTENTS
Contact Us for Counseling................................................................................................... 2
How We Reignited Our Passion for Intimacy after Prostate Cancer........................................ 3
By Steve Frohman and Cindie Hubiak
Optimizing Outcomes of Advanced Prostate Cancer:
Drug Sequencing and Novel Therapeutic Approaches........................................................... 6
By E. David Crawford, MD and Thomas W Flaig, MD
What the Heck Has Been Going On In My World - Part 57....................................................... 9
By Mark A Moyad, MD, MPH
Staying Active with Urinary Incontinence: You Don’t Have to Use Diapers............................ 15
A Strange Place – Part V................................................................................................... 17
By T.R. Herbert
Letters to the Editor......................................................................................................... 19
PCRI Conference Information and Agenda......................................................................... 20
Acknowledgements......................................................................................................... 21
Financial Summary Report............................................................................................... 23
PAACT Membership Form.................................................................................................. 24
How We
Reignited
Our Passion
for Intimacy
after Prostate
Cancer
B y
S te v e
F r o h m an
Steve
One in six men in America today is affected by prostate
cancer. According to the American Cancer Society, more
than two million men living in the United States have been
diagnosed with prostate cancer at some point in their life. I
am one of those.
Women are impacted by prostate cancer at an exponential
rate. After all, most men relate to more than one woman. In
addition to being a husband/lover, men connect to women
as fathers, brothers, uncles, colleagues and friends. Almost
every woman could tell you a story about a man in her life
diagnosed with prostate cancer. I am one of those stories.
Cindie
Steve and I learned early on that the survival rate from
prostate cancer is extremely high, which we found
comforting. We also learned that even with the latest nervesparing surgery techniques or the most accurate delivery of
radiation treatment, there was a high possibility that Steve’s
physical ability to engage in an intimate relationship would
be negatively impacted, at least to some degree.
Our journey from just surviving cancer to living a sexually
fulfilled life was full of challenges we didn’t anticipate.
an d
C i n d i e
H u b i a k
Many of the physical aspects we enjoyed in our relationship
disappeared after Steve’s prostate was removed. This
negatively impacted our entire relationship, until we learned
to look at sex in a whole new way.
At first, Steve and I focused on all the traditional medical
solutions with little success. The breakthrough came when we
were able to better define the problem as a lack of intimacy
and sexual fulfillment. We expanded the “playing field” and
created dozens of solutions for intimacy.
It didn’t start that way though. We took many wrong turns
and lived in survival mode longer than needed. Soon after
Steve’s diagnosis, he withdrew. Using a laser-like focus, he
researched his options to remove the cancer from his body. I
didn’t know how to reach him, and his distance caused me to
withdraw from the relationship as well.
As we reflect back, we see how we approached Steve’s
diagnosis and our less than satisfying sex life from our own
unique perspectives. In the beginning Steve and I didn’t
fully appreciate how men and women approach and solve
problems in different ways.
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 3
asked Cindie to keep my diagnosis
“As we got to Iprivate.
She resisted, but I insisted. I’m
a
private
and didn’t want anyone
know ourselves to know. Iperson
didn’t realize, at the time, how
better and took painful she would find this seemingly
simple request.
responsibility for
wasn’t overly interested in sex after
ourselves—voila— Itreatment.
I’m embarrassed to say I
just ignored our lack of intimacy. We
we achieved
lived a busy life and everything seemed
Fortunately, Steve and I kept exploring
What I didn’t realize is that we
sexual fulfillment okay.
ways to improve our intimacy until we
were drifting apart and living more like
found what worked. I didn’t want to be
roommates. I also didn’t realize how
and
saved
our
like a woman I had met who had divorced
unhappy Cindie had become.
after 16 years of marriage because of the
marriage.”
isolation and lack of sexual fulfillment
Cindie’s Story
We were also very good at avoidance, a
common human trait. Too often it was
easier to ignore our lack of intimacy
rather than address it. We found ourselves
growing apart because of the cancer
diagnosis and treatment, rather than
allowing the experience to bring us
closer together. Based on conversations
with other men and women impacted by
prostate cancer, this happens frequently.
in her marriage.
Our individual stories follow, along with five tips for
reigniting passion for intimacy after prostate cancer.
Steve’s Story
It was May of 2007, early on a Friday evening at the
Jefferson Hotel in Richmond, Virginia. The mood of the
group was festive as we were celebrating the retirement of
a business associate.
I felt apprehension, as it was still late afternoon in Phoenix.
I nervously anticipated a phone call from my urologist with
my latest biopsy results. This was my third biopsy over a
15-year period. I had a history of an enlarged prostate and
high PSA score ever since my first PSA test in my mid 40’s.
When my cell phone vibrated, I quickly stepped into the
ballroom foyer to take the call.
Dr. Bans let me know that the results of the biopsy were
positive, indicating cancer had been found. Although no
cancer is good, he explained that my cancer was a less
aggressive form. This meant there was time to evaluate
and select the best treatment method for my situation.
I know he intended this information to be somewhat
comforting, and it was, in a small way; though the fact
still remained…I had cancer.
Over the next few weeks and months, I worked closely
with Dr. Bans, Cindie and a close friend to put a plan
in place. I wanted to further understand and evaluate
my situation, select a treatment option and undergo
treatment. I ultimately selected surgery, and my prostate
was removed six months later.
4
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
I didn’t engage a great deal in Steve’s search for treatment
options. He answered my questions, I went to San Francisco
with him for a second opinion and I met his surgeon once
before the surgery. Early attempts to engage more with Steve
didn’t work. He seemed to prefer to handle the situation
alone, so I gave up and went on with my life.
Initially we focused on Steve’s recovery, ignoring my growing
unhappiness. After all, I didn’t have cancer and my body
hadn’t undergone an intense surgical procedure. Although,
after several quarterly zero PSA tests, I still found myself
struggling in a relationship that didn’t work for me.
Steve’s diagnosis and treatment impacted me physically,
emotionally and spiritually. I didn’t like myself after Steve’s
recovery. I didn’t feel desired as a woman and my selfconfidence plummeted. Steve wasn’t interested in sex;
something we learned later that is quite common in men
treated for prostate cancer.
Eventually, I discovered that I had to address my issues if
I wanted to find happiness. I would have to take the lead
if I wanted to save our marriage. When I began to take
responsibility for my situation and stopped blaming Steve,
our relationship improved. When I got over feeling sorry for
myself and settling for an unhappy marriage, I discovered
ways to take the initiative to create a life where Steve and I
looked at sex differently than we did before prostate cancer.
Steve - Reigniting Our Passion for Intimacy
When Cindie and I began looking for ways to increase
our intimacy, we started by defining sexual fulfillment. My
definition included emotional closeness, physical intimacy
and mental intensity. I used words like trust, passion,
vulnerability, oneness and excitement.
Cindie used a technique called circle drawing to uncover
her definition of sexual fulfillment. She discovered sexual
fulfillment meant aliveness, freedom, becoming one God
and an opportunity to get to know herself better.
Cindie and I didn’t possess the skills necessary to reach
sexual fulfillment, so we sought outside assistance. Cindie
started an intensive study of men, improving her ability to
communicate with me in order to get her needs met. We
both uncovered destructive childhood patterns that required
breaking.
We spent time with a tantrika, a woman who honors the
beauty and fullness of sexuality and uses her knowledge to
assist others. We learned how to move energy, the importance
of slowing down and the necessity of scheduling time for
intimacy.
Cindie and I also realized we each needed to go through
a grieving process before we could completely heal and
experience sexual fulfillment. We talked about our own
mortality; the elephant in the room cloaked with our
unspoken fears about death and being alone.
As we got to know ourselves better and took responsibility
for ourselves—voila—we achieved sexual fulfillment and
saved our marriage. Today we live a thriving life, filled with
appreciation from our prostate cancer journey that brought
us closer together than we had ever imagined. We followed
five steps to reignite the passion in our life and in our
relationship:
• Grieve. Anyone impacted by prostate cancer experiences
immense change. Change means loss, which goes hand
in hand with grief. You need to go through the process of
the five commonly accepted stages of grief: anger, denial,
bargaining, depression and acceptance. Then go through
the process of these emotions again. Your experience
will be unique. You may skip a stage or bounce backand-forth between several stages. Cindie and I live in the
acceptance stage most of the time, assisting each other to
grieve more when needed.
• Explore different solutions. Rely on a combination
of resources, both traditional and non-traditional, to
achieve a fulfilling sex life. Traditional resources include
your urologist, other medical professionals and the use
of pharmaceuticals. Non-traditional resources include a
naturopathic physician, a psychologist, a hypnotherapist,
a tantrika and a chiropractor. By balancing the benefits of
high-technology Western medicine with the practices of a
more holistic approach, Cindie and I ultimately achieved a
more fulfilling relationship than we had ever imagined.
• Define and devote time to intimacy. Too often couples
define intimacy as achieving a physical destination, i.e.
an orgasm. Explore how you can broaden that definition.
Learn how to look at your intimate relationship as a
journey, one without a destination. You can do this best
by scheduling intimate time together each week. Get
to know each other’s bodies without an expectation of
orgasm. Use all five senses during your intimate time
and slow down. Christie and I amazed ourselves at the
increased levels of pleasure we experienced simply by
slowing down and expanding our awareness.
• Excellent communications. You achieve high levels
of intimacy results when you, as partners, share
feelings rather than thoughts. Learn what makes a safe
environment for each other to make sure feelings are
shared easily. Recognize the different communication
styles of men and women. When I learned to just listen
to Cindie without fixing the problem, she relaxed and felt
closer to me. When Cindie learned to get my attention
and make requests using a specific formula, I began to
meet her needs every time.
• Believe in a thriving life. Know that you can do it.
Commit to taking the journey. Be open to experiment.
If you want a different result you must take a different
action. You’ll find things that don’t work for you as a
couple, stop doing them. You’ll also find things that do
work for you in your relationship, so make sure you do
those things more often. By doing this you’ll be creating
the journey of a lifetime. Let Cindie and I know what
works for you.
Today, we celebrate Steve living cancer-free for more than
four years. We also celebrate living a sexually fulfilled life.
Steve Frohman and Cindie Hubiak, co-founded Solutions For
Intimacyв„ў to help men, women and couples get to the root
of their intimacy struggles and enable them to live a sexually
fulfilled life after prostate cancer. The program’s cornerstone
– The Personal Approach – addresses the physical, emotional
and spiritual aspects of intimacy.
Cindie recently published a book titled “A Woman’s Guide
to Thriving after Prostate Cancer.” It helps women and men
gain new ideas, understanding and skills from her journey
through what’s typically considered a man’s disease. She
writes a weekly Intimacy Tip posted on the Solutions For
Intimacy Facebook page.
They can be reached at 480-607-6850 or
www.SolutionsForIntimacy.com.
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 5
Optimizing Outcomes
of Advanced Prostate
Cancer: Drug Sequencing
and Novel Therapeutic
Approaches
By E. David Crawford, MD and Thomas W Flaig, MD
University of Colorado Cancer Center and
the University of Colorado School of Medicine, Aurora
Abstract: The rapid approval of several novel agents has given
prostate cancer patients and their treating physicians many
new and effective therapeutic options. Three new medical
therapies were recently approved on the basis of prolonged
overall survival in castration-resistant prostate cancer patients:
sipuleucel-T (Provenge), cabazitaxel (Jevtana), and abiraterone
acetate (Zytiga). Additionally, there are several other promising
prostate cancer agents in late-stage development, including
MDV3100, PROSTVAC-VF (Prostvac), orteronel (TAK-700),
and radium-223 chloride (Alpharadin), each with a novel
mechanism of action. Taken together, we have entered a period
of accelerated drug development and optimism in the care of
advanced prostate cancer. The treatment paradigm for these
patients is rapidly evolving, with future study needed to define
the optimal sequencing and potential combinations of these
new agents.
Introduction
Last year marked the start of an accelerated period of drug
development for advanced prostate cancer. While gonadotropinreleasing hormone (GnRH) agonists and anti-androgens were
approved in the 1980s docetaxel, approved for prostate cancer
in 2004, had been the only modern chemotherapy agent
to demonstrate an overall survival advantage for men with
castration-resistant prostate cancer (CRPC). Three new medical
therapies were recently approved on the basis of prolonged
over-all survival in CRPC patients: sipuleucel-T (Provenge),
cabazitaxel (Jevtana), and abiraterone acetate (Zytiga). Tables 1
and 2 provide further information about these agents; Table 2
also compares them with docetaxel and highlights their efficacy,
safety and costs. In addition, a novel new bone-targeting
monoclonal antibody, denosumab (Xgeva), and an LHRH
antagonist, degarelix (Firmagon), have been introduced into
clinical practice. [1]
6
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
With the rapid introduction of these agents, questions arise
about their optimal sequencing, in the context of our existing
therapies. There are also many other novel agents currently
under active development for prostate cancer, including a
significant number in late-stage, phase III clinical trials for
prostate cancer.
Sipuleucel-T (Provenge)
Sipuleucel-T was approved by the FDA in April 2010 for
use in men with metastatic CRPC that is asymptomatic or
minimally symptomatic (Table 1). It represents a first-in-class
agent, classified as an autologous cellular immunotherapy.
The manufacturing process for sipuleucel-T is unique and
integral. Patients initially undergo collection of peripheralblood mononuclear cells via leukapheresis, for enrichment for
antigen-presenting cells. The patient’s blood is then delivered
to a central manufacturing site, where it is processed with the
recombinant fusion protein PA2024 (ProACT), which contains
both antigenic (prostate acid phosphatase) and stimulatory
(granulocyte-macrophage colony-stimulating factor) elements.
This autologous, ex vivo loaded product is then shipped
back to the patient and infused approximately 3 days after
collection. This process takes place three times over a period of
approximately 4 weeks. [2]
Sipuleucel-T was initially tested in a small study of 127 patients
with symptomatic CRPC. [3] Subjects were randomized in 2:1
fashion to sipuleucel-T vs. placebo. The primary endpoint was
time to progression (TTP), with a secondary endpoint of overall
survival; crossover to active therapy in those initially randomized
to placebo was allowed. The median TTP was 11.7 weeks vs.
10.0 weeks, favoring sipuleucel-T, but this was not statistically
significant (P = .052). Median overall survival, however, was
statistically significantly improved with sipuleucel-T, at 25.9
months vs. 21.4 months with placebo (P = .01).
Table 1: Recently Approved Agents for Castrate-Resistant Prostate Cancer (CRPC)
Name
Class
FDA Approval
Regimen
Mechanism of Action
Disease Setting
Comments
Sipuleucel-T
Autologous cellular
immunotherapy
April 2010
Doses (IV) every 2
weeks x 3 doses
Ex-vivo processing of
patient’s dendritic cells
with PA2024
CRPC, metastatic
with minimal or no
symptoms
Patient’s blood is collected via leukapheresis and
shipped to a central facility for processing; no PFS
advantage noted
Cabazitaxel
Microtubule inhibitor
June 2010
25 mg / m2 IV
every 3 weeks with
prednisone 10 mg
PO daily
Microtubule
stabilization
CRPC, metastatic
after docetaxel
chemotherapy
Increased incidence of neutropenia and
neutropenic fever noted in phase III trial
Abiraterone
acetate
CYP 17 inhibitor
April 2011
1000 mg PO daily
with prednisone 5
mg PO BID
Inhibits androgen
synthesis in adrenal
gland and prostate
cancer cells
CRPC, metastatic
after docetaxel
chemotherapy
Associated with symptoms of mineralcorticoid
excess (hypertension, edema, hypokalemia)
Denosumab
(Xgeva)
RANK ligand inhibitor
November
2010
120 mg SQ every
month
Human monoclonal
antibody against RANK
ligand
CRPC, metastatic
bone disease
For the prevention of skeletal-related events
Denosumab
(Prolia)
RANK ligand inhibitor
September
2011
60 mg SQ every 6
months
Human monoclonal
antibody against RANK
ligand
High-risk for
skeletal-related
event while on ADT
for prostate cancer
(nonmetastatic)
To increase bone mineral density in those on ADT
and at high risk in the nonmetastatic setting
ADT = androgen-deprivation therapy; BID = twice daily; IV = intravenous; PFS = progression-free survival; PO = by mouth; RANK = receptor activator
of nuclear factor kappa-B; SQ = subcutaneous.
Table 2: Docetaxel Compared with Three Recently Appproved Agents for Castration-Resistant Prostate Cancer
Trade Name
Taxotere
Jevtana
Provenge
Zytiga
Generic Name
docetaxel
cabazitaxel
sipuleucel-T
abiraterone
Indication
For treatment of
metastatic (m+) CRPC
For treatment of m+CRPC in
m+CRPC with no or few symptoms due
combination with prednisone after to the PC (asymptomatic)
prior treatment with docetaxel
Clinical
(Efficacy vs.
control)
For treatment of m+CRPC in combination
with prednisone after prior treatment with
docetaxel
2.4 months [5.6]
2.4 months [9]
4.1 months [2]
4.6 months [15]
-23.90%
-30.00%
-22.50%
-26%
Safety / Tolerability
Side effects such as
infections and bone
marrow suppression
Side effects such as neutropenia
including fatal outcomes, severe
hypersensitivity, and diarrhea
Side effects such as chills, fever, back
pain, nausea, joint ache, and headache
(peri-infusional)
Hypokalemia edema, and hypertension
Treatment Method and
Duration
1 hour IV every 3 weeks for
7-10 cycles
1 hour IV every 3 weeks - multiple
cycles
3 - 4 hour cell collection, 1 hour
reapplication (IV) every 2 weeks for 3
treatments
Oral administration once daily - continuously
Cycles of Therapy
10 cycles
6 cycles
3 treatments
8 months
Cost of Therapy
$2,412 / cycle
$8,000 / cycle
$31,000 / treatment
$5,000 / month
Total Cost of Treatment
(including administration
cost, adverse event [AE]
management, etc.)
$24,120 (not including
administration costs, AE
management, etc.)
$48,000 (not including
administration costs, AE
management, etc.)
$93,000
$40,000 (not including AE management, etc.)
Setting
Chemotherapy
Post-Chemotherapy
Pre-Chemotherapy
Post-Chemotherapy
Overall survival (months)
Risk of death
To follow up on these findings, a larger study was initiated. [2]
This phase III trial included 512 subjects with metastatic CRPC
who were randomized in 2:1 fashion to sipuleucel-T or placebo.
Overall, therapy was well tolerated, with serious adverse events
(grade 3-5) observed in 31.7% of sipuleucel-T treated subjects,
vs. 35.1% of those in the placebo group. Adverse events that
were more frequently observed in the sipuleucel-T group
included chills (54.1%), pyrexia (29.3%), and headache (16.0%).
The median overall survival time was 25.8 months with
sipuleucel-T treatments vs. 21.7 months in those randomized
to placebo, remarkably similar to the survival results from
the earlier randomized study. It is notable that 63.7% of those
in the placebo arm did receive sipuleucel-T at some point in
their subsequent treatments. The median survival of those in
the placebo group who received delayed sipuleucel-T was 23.8
months vs. 11.6 months in those who did not. The median time
to objective disease progression and clinical disease progression
was not different between the two treatment groups. One of the
challenges with the use of sipuleucel-T is the lack of prostatespecific antigen (PSA) responses as a marker to evaluate activity.
There are few published data on activity of sipuleucel-T in
the hormone-responsive or hormone-naГЇve prostate cancer
state. In a study by Beer, et al., 176 patients with hormonedependent prostate cancer and biochemical relapse after radical
prostatectomy were randomized in a 2:1 ratio to 3 to 4 months
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 7
of androgen-deprivation therapy (ADT), with or without
sipuleucel-T. [4] The median time to biochemical failure was
not statistically different in the sipuleucel or control groups (18.0
vs. 15.4 months, respectively), although those with sipuleucel-T
treatment did have a longer PSA doubling time (155 vs. 105
days; P = .038. Based on the previous CRPC studies, overall
survival may be more informative than TTP endpoints, and
survival data for this study will require additional follow-up.
Cabazitaxel (Jevtana)
Cabazitaxel was approved by the FDA in June 2010 for treatment
of metastatic CRPC after treatment failure with docetaxel
chemotherapy (Table 1). As discussed, docetaxel was approved
for CRPC in 2004, and until 2010 it was the only agent to
demonstrate a survival advantage in patients with CRPC. [5,6]
Like docetaxel, cabazitaxel is a non-cross-resisted microtubule
target agent, promoting tubulin assembly and thereby stabilizing
the microtubule to the point of biological consequence.
In preclinical studies, cabazitaxel showed activity in a variety
of chemotherapy-resistant cell lines and was more active than
docetaxel in several models. [7] Phase I testing of cabazitaxel
was reported in 2009, with dose-limiting neutropenia, but little
neurotoxicity was observed. [8]
In phase III testing 775 men with metastatic CRPC who had
received previous docetaxel chemotherapy were randomized
to prednisone with either cabazitaxel (at 25 mg/m2) or
mitoxantrone (at 12 mg/m2), each given every 3 weeks. [9]
The overall survival was 15.1 months with cabazitaxel, vs. 12.7
months with mitoxantrone (P < .0001). The most common
toxicities in the cabazitaxel arm were related to bone-marrow
suppression, with grade 3 or higher neutropenia in 82 % of
the cabazitaxel-treated patients vs. 58% of the mitoxantronetreated patients. Additionally, febrile neutropenia was seen in
8% of those in the cabazitaxel arm compared with only 1%
of the mitoxantrone arm. Diarrhea was also more common
with cabazitaxel therapy, seen in 47% of patients, with 6%
experiencing grade 3 or higher diarrhea.
Abiraterone Acetate (Zytiga)
Abiraterone acetate was approved by the FDA in April 2011
for the treatment of men with metastatic CRPC following
docetaxel chemotherapy (Table 1). It is an oral inhibitor of
CYP17, a key driver of testosterone production. While GnRH
agonist/antagonist therapy reduces systemic testosterone
production by 90% to 95% (via testicular suppression), the
adrenal glands and some prostate cells themselves continue
to synthesize testosterone despite GnRH agonist/antagonist
treatment. Abiraterone acetate therapy directly suppresses
this extragonadal testosterone production, yielding systemic
testosterone levels approaching 0 ng/dL. [10,11]
8
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
Early phase I and II studies established activity of abiraterone
acetate in CRPC. The Initial phase I study of abiraterone acetate
in CRPC escalated the dose from 250 to 2000 mg daily, with
a recommended phase II dose of 1000 mg daily. [10] While
generally well tolerated, increased levels of upstream steroids,
including adrenocorticotropic hormone, were observed and
side effects associated with mineralocorticoid excess were noted.
In subsequent studies, dexamethasone, and later prednisone at 5
mg twice daily, was given with abiraterone to partially abrogate
the accumulation of excess mineralocorticoid. [12] Across
several of these studies, the rate of PSA responses (reductions
of ≥ 50%) ranged from 36% to 67%. [10-14] Notably, subjects
with previous ketoconazole treatment given the similarities
of ketoconazole’s adrenal-suppressive action) generally had a
lower PSA response rate. [14]
A phase III study of abiraterone randomized 1195 subjects with
metastatic CRPC and progression after docetaxel chemotherapy.
[15] Participants received prednisone with or without 1000 mg
of abiraterone acetate daily in a 2:1 ratio. Abiraterone acetate
was well tolerated overall, although events associated with
mineralocorticoid excess including fluid retention/edema
(31%), hypokalemia (17%), and hypertension (10%) were
observed more frequently in the abiraterone group. The median
overall survival was 14.8 months with abiraterone acetate
treatment, compared with 10.9 months in the placebo arm (P
< .001). Secondary endpoints of PSA progression (10.2 months
vs. 6.6 months, respectively), progression-free survival (PFS)
(5.6 months vs. 3.6 months, respectively), and PSA response
rate (29% vs. 6%, respectively), all favored abiraterone acetate
therapy.
Denosumab (Xgeva)
Denosumab (Xgeva) was approved by the FDA in November
2010 for prevention of skeletal-related events (SREs) in patients
with bone metastases from solid tumors (Table 1). A dynamic
bone environment exists in normal bone, with a balance
between bone production via osteoblasts and bone resorption
via osteoclasts. SREs are common in prostate cancer due to
dysregulation of bone formation/resorption, bone metastases
themselves, and loss of bone mineral density associated
with ADT. Receptor activator of nuclear factor kappa-B
(RANK) ligand is critical to osteoclast formation and survival.
Denosumab is a human monoclonal antibody against RANK
ligand and it inhibits bone-resorption activity of osteoclasts.
In a phase III study of bone metastases and CRPC, 1904 men
were randomized to denosumab (at 120 mg SQ) or zoledronic
acid (Zometa; at 4 mg IV) every 4 weeks. [16] Median time to
observance of the first SREs was 20.7 vs. 17.1 months, favoring
denosumab (P = .008). No overall survival difference was seen.
Hypo-calcemia (P < .0001) and osteonecrosis of the jaw (P =
.09) were noted more frequently in the denosumab group.
In addition to its initial label indication, denosumab was
approved (under the trade name Prolia) in September 2011 to
increase bone mass in patients who are at high risk of fracture
and also are receiving ADT for nonmetastatic prostate cancer. In
contrast to the dosing for metastatic CRPC, denosumab is given
as a subcutaneous injection (Prolia, at 60 mg) every 6 months
in the nonmetastatic setting. In the phase III study leasing to
this indication, high-risk prostate cancer subjects treated with
ADT who were without bone metastases were randomized to
denosumab or placebo, with 734 men in each group. [17] Highrisk was defined as being 70 years of age or older, having low
bone mineral density with a T score of < - 1.0, or having a history
of an osteoporotic fracture. After 2 years on the study, the bone
mineral density of the lumbar spine in the denosumab-treated
group increased by 5.6%, while it had decreased 1.0% in the
placebo group (P < .001). Those treated with denosumab also
had fewer new vertebral fractures at 36 months (1.5% vs. 3.9%,
P = .006).
A recently completed clinical trial in high-risk prostate cancer
patients after local therapy revealed that denosumab is capable of
delaying the development of bone metastasis. This study enrolled
1432 subjects with nonmetastatic CRPC and randomized them
to denosumab (120 mg every 4 weeks) or placebo. The time to
first metastasis was delayed by approximately 4 months in the
denosumab-treated group. [18]
REFERENCE GUIDE:
Therapeutic Agents Mentioned in This Article
Abiraterone acetate (Zytiga)
Anti-androgens
Cabazitaxel (Jevtana)
Degarelix (Firmagon)
Denosumab (Xgeva, Prolia)
Docetaxel
Gonadotropin-releasing hormone
agonists/antagonists
Granulocyte-macrophage colonyStimulating factor
Ipilimumab (Yervoy)
Ketoconazole
MDV3100
Mitoxantrone
Orteronel (TAK-700)
PA2024 antigen (ProACT)
Prednisone
Prostate acid phosphatase
PROSTVAC-VF (Prostvac)
Radium-223 chloride (Alpharadin)
Sipuleucel-T (Provenge)
Strontium-89
Tasquinimod
Zoledronic acid (Zometa)
Brand names are listed in parentheses only if a drug is not
available generically and is marketed as no more than two
trademarked or registered products. More familiar alternative
generic designations may also be included parenthetically.
*Not all of these Therapeutic Agents appear in Part 1 of this
article.
This article is being printed in a multi-part series. The next
series will continue with “Sequencing of Medical Therapy in
Advanced Prostate Cancer.”
This article originally appeared in ONCOLOGY in the
January 2012 Issue
ADDRESS ALL CORRESPONDENCE TO:
David Crawford, MD
Division of Medical Oncology, University of Colorado Cancer
Center and the University of Colorado School of Medicine
PO Box 6510, Mailstop F743
Aurora, CO 80045
david.crawford@ucdenver.edu
References:
1. National Comprehensive Cancer Network: NCCN Guidelines. Version 4.2011.
Prostate Cancer. Available at http://www.nccn.org/index.asp.
2. Kantoff PW, Higano CS, Shore ND, et al. Sipuleucel-T immunotherapy for castrationresistant prostate cancer. N Engl J Med. 2010;363:411-22.
3. Small EJ, Schellhammer PF, Higano CS, et at. Placebo-controlled phase III trial of
immunologic therapy with sipuleucel-T (APC8015) in patients with metastatic,
asymptomatic hormone refractory prostate cancer. J Clin Oncol. 2006;24:3089-94.
4. Beer TM, Bernstein GT, Corman JM, et al. Randomized trial of autologous cellular
immunotherapy with sipuleucel-T in androgen-dependent prostate cancer. Clin
Cancer Res. 2011;17:4558-67.
5. Petrylak DP, Tangen CM, Hussain MH, et al. Docetaxel and estramustine compared
with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl
J Med. 2004;351:1513-20.
6. Tannock IF, de Wit R, Berry WR, et al. Docetaxel plus prednisone or mitoxantrone
plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502-12.
7. Bissery M, Bouchard H, Riou JF, et al. Preclinical evaluation of TXD25, a new taxoid
(abstract 1364). Proc Am Assoc Cancer Res. 2000;41:214.
8. Mita AC, Denis LJ, Rowinsky EK, et al. Phase I and pharmacokinetic study of
XRP6258 (RPR 116258A), a novel taxane, administered as a 1-hour infusion every
3 weeks in patients with advanced solid tumors. Clin Cancer Res. 2009;15:723-30.
9. de Bono JS, Oudard S, Ozguroglu M, et al. Prednisone plus cabazitaxel or
mitoxantrone for metastatic castration-resistant prostate cancer progressing after
docetaxel treatment: a randomized open-label trial. Lancet. 2010;376:1147-54.
10. Attard G, Reid AH, Yap TA, et al. Phase I clinical trial of a selective inhibitor of
CYP17, abiraterone acetate, confirms that castration-resistant prostate cancer
commonly remains hormone driven. J Clin Oncol. 2008;26:4563-71.
11. Ryan CJ, Smith MR, Fong L, et al. Phase I clinical trial of the CYP17 inhibitor
abiraterone acetate demonstrating clinical activity in patients with castrationresistant prostate cancer who received prior ketoconazole therapy. J Clin Oncol.
2010;28:1481-8.
12. Attard G, Reid AH, A’Hern R, et al. Selective inhibition of CYP17 with abiraterone
acetate is highly active in the treatment of castration-resistant prostate cancer. J Clin
Oncol. 2009;27:3742-8.
13. Reid AH, Attard G, Danila DC, et al. Significant and sustained antitumor activity
in post-docetaxel, castration-resistant prostate cancer with the CYP 17 inhibitor
abiraterone acetate. J Clin Oncol. 2010;28:1489-95.
14. Danila DC, Morris MJ, de Bono JS, et al. Phase II multicenter study of abiraterone
acetate plus prednisone therapy in patients with docetaxel-treated castrationresistant prostate cancer. J Clin Oncol. 2010;28:1496-501.
15. de Bono JS, Logothetis CJ, Molina A, et al. Abiraterone and increased survival in
metastatic prostate cancer. N Engl J Med. 2011; 364:1995-2005.
16. Fizazi K, Carducci M, Smith M, et al. Denosumab versus zoledronic acid for
treatment of bone metastases in men with castration-resistant prostate cancer: a
randomized, double-blind study. Lancet 2011; 377:813-22.
17. Smith MR, Egerdie B, Hernandez Toriz N, et al. Denosumab in men receiving
androgen-deprivation therapy for prostate cancer. N Engl J Med. 2009;361:745-55.
18. Smith MR, Saad F, Coleman R, et al. Denosumab and bone-metastasis-free survival
in men with castration-resistant prostate cancer: results of a phase 3, randomized,
placebo-controlled trial. Lancet, 2011 Nov 15. [Epub ahead of print]
19. Tran C, Ouk S, Clegg NJ, et al. Development of a second-generation antiandrogen
for treatment of advanced prostate cancer. Science. 2009;324:787-90.
20. Scher HI, Beer TM, Higano CS, et al. Antitumor activity of MDV3100 in castrationresistant prostate cancer: a phase 1-2 study. Lancet. 2010;375:1437-46.
21. Medivation and Astellas Oncology: Medivation and Astellas Announce Positive
Survival Data From Interim Analysis of Phase 3 AFFIRM Trial of MDV3100 in
Men With Advanced Prostate Cancer [news release]. Available at: http://investors.
medivation.com/releasedetail.cfm?ReleaseID=620500.
22. DiPaola RS, Plante M, Kaufman H, et al. A Phasse I trial of pox PSA vaccines
(PROSTVAC-VF) with B7-1, ICAM-1, and LFA-3 co-stimulatory molecules
(TRICOM) in patients with prostate cancer. J Transl Med. 2006;4:1.
23. Arlen PM, Skarupa L, Pazdur M, et al. Clinical safety of a viral vector based prostate
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 9
cancer vaccine strategy. J Urol. 2007;178:1515-20.
24. Kantoff PW, Schuetz TJ, Blumenstein BA, et al. Overall survival analysis of a phase
II randomized controlled trial of a poxviral-based PSA-targeted immunotherapy in
metastatic castration-resistant prostate cancer. J Clin Oncol. 2010;28:1099-105.
25. Kaku T, Hitaka T, Ojida A, et al. Discovery of orteronel (TAK-700), a
naphthylmethylimidazole derivative, as a highly selective 17,20-lyase inhibitor
with potential utility in the treatment of prostate cancer. Bioorg Med Chem.
2011;19:6383-99.
26. Bruland OS, Nilsson S, Fisher DR. Larsen RH, High-linear energy transfer irradiation
targeted to skeletal metastases by the alpha-emitter 223Ra: adjuvant or alternative to
conventional modalities? Clin Cancer Res. 2006;12:6250s-7s.
27. Journal of the National Cancer Institute: 103 ESMO Parker Transcript [podcast].
Available at: http://www.oxfordjournals.org/our_journals/jnci/podcast/transcript_
interview_103-esmo.html.
28. Flaig TW, Tangen CM, Hussain MH, et al. Randomization reveals unexpected
acute leukemias in Southwest Oncology Group prostate cancer trial. J Clin Oncol
2008;26:1532-6.
29. Dorff TB, Flaig TW, Tangen, CM, et al. Adjuvant androgen deprivation for highrisk prostate cancer after radical prostatectomy: SWOG S9921 study. J Clin Oncol.
2011;29:2040-5.
WHAT THE
HECK HAS BEEN
GOING ON IN MY
WORLD-PART 57!
By Mark A. Moyad, MD, MPH
University of Michigan
Note: A total of 57 times in a row (and for over 10 years…actually I think almost 15
years) I have written and volunteered for this newsletter, and I have yet to receive any
financial compensation or personalized gifts; such as a Michigan Co-Big Ten Champions
Basketball Jersey (we shared the title with that school to the North and South of us), a free
case of Diet Mountain Dew or even a bottle of 5-hour energy to keep me awake at night
when I am working on this column!
BREAKING NEWS STORY FROM THE Early Access Program
for Prostate Cancer Patients Committee (EAPPCPa; an allvolunteer organization made up of health care professionals
and patient advocates from around the U.S.)
223) MDV3100 is a pill for those with hormone refractory
prostate cancer (HRPC, also known as CRPC….) from
“Medivation” and “Astellas” and there is also an IV drug
for metastatic HRPC known as Alpharadin ([radium-223
chloride] from “Algeta” and “Bayer”). Both of these
drugs will be available soon for men that are in need of
more options right now! However, Alpharadin is already
available for some men that are running out of options
through an Early Access Program (EAP). Continue to
follow the PAACT website for updates!
(Reference: Moyad and Friends, 2011)
Bottom Line:
MDV-3100 is an oral daily drug used after no longer responding
10
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
to taxotere chemotherapy and should be available through
an early access program (EAP) soon. Alpharadin is an IV
radiopharmaceutical drug that helps men with bone pain from
HRPC and also improves survival which should also be available
soon. Alpharadin is arguably less well known right now, but the
company has already opened up an early access program for
patients that are in need of the drug right now!
What else?
PAACT, PCRI, US TOO, and Zero prostate cancer patient
advocacy groups have volunteered their time and resources to
bring you the latest and greatest information on the latest drugs
being made available to prostate cancer patients. Please go to
their websites for more information.
224) Metformin could potentially help some men with
early stage prostate cancer? How groovy is this! (Note:
groovy is an endearing 1970s and 1980s term that I
picked up from watching shows like the Brady Bunch,
Partridge Family, Starsky & Hutch and Disco Movies…)
(Reference: Joshua A, et al. Presentation at the American Association of
Cancer Research Annual Meeting, 2012)
Bottom Line:
WHAT A GREAT LITTLE STUDY! Metformin, one of the
cheapest and oldest drugs (pills) used for type-2 diabetes may
help men with prostate cancer, but more research is needed
(and in reality the words “more research is needed” is the most
politically correct adage in all of medicine).
What else?
I have talked and written about this prescription drug before
mucho (many) times, and the news just keeps getting better, so
why not continue to write about it? Okay, I will continue - good
idea! Metformin is not only a cheap generic drug, but has a
long-term safety record and has helped a lot of adults not only
lose weight but prevent type-2 diabetes for those individuals
at a higher risk for this condition. Yet, metformin’s ability
to potentially prevent and help with certain types of cancer
treatment is getting interesting and more impressive by the day.
We need to keep watching the research on this drug!
In a phase 2 study completed at the Princess Margaret Hospital
- Ontario Cancer Institute and Jewish General Hospital - McGill
University, men with localized prostate cancer took as much as
500 mg of metformin 3 times a day for as little as 4 to 12 weeks
before their radical prostatectomy. After prostate removal the
researchers noted that certain indices that reflect tumor growth
itself appeared to be impacted by metformin. In other words,
it appeared that metformin was significantly reducing tumor
growth. Now there was no control group and there were
slightly over 20 men that participated in this study, but it is still
impressive if you consider all the other areas of cancer where
metformin seems to be helping some men and women. In this
study, metformin also appeared to control or reduce PSA in
most of the men in a very short time. Here is what we already
know about metformin (if you have been reading my column or
have followed the medical journals):
• It is a heart healthy drug
• It helps control blood glucose, insulin, and IGF-1 levels
• It helps some men and women (diabetics and nondiabetics) lose weight safely
• It even seems to help some men on hormone therapy
(LHRH) for prostate cancer, to lose weight
• The side effect rate is so low, I could argue that it should
be available over the counter at lower doses
• It can reduce the risk of being diagnosed with type 2
diabetes
• It is being studied in a phase 3 trial in breast cancer patients
right now
• It appears to be slowing the growth of many tumor types in
the lab and in humans
• The results are preliminary and this drug could still turn
out to be worthless against cancer but in the meantime it
has to be one of the more exciting stories in medicine.
KEEP AN EYE ON THIS DRUG! IT IS SO FASCINATING!!!
(see how many exclamation points I used there…I must really
like it).
225) 7 Parameters that could dramatically improve the
lives of many people and reduce the risk of dying from
many causes, and only 1-2% of Americans are following
these things!?! (Oops - there goes another exclamation
point)
(Reference: Yang Q, et al. JAMA 2012; published early on-line March 16,
2012)
Bottom Line:
The greater the number of heart healthy behaviors and
parameters, the greater the positive impact on cardiovascular
health and reducing the risk of dying from numerous causes
(also known as “all-cause mortality”). However, only 1-2%
of individuals in the U.S. have ideal maximum heart healthy
behaviors and measurements.
What else?
The American Heart Association (AHA) recommends 7
cardiovascular health metrics (numbers and lifestyle changes)
that include: no tobacco, exercise, normal blood pressure,
blood glucose, total cholesterol, and weight; and consuming
a healthy diet. So, a recent study attempted to examine the
“We need more
studies that
address long-term
pain medication
use after a lowrisk surgery in
individuals that
had not utilized
these medications
previously.”
impact of making none, some, or all of the metrics or changes
and the results were STUNNING! Data from the National
Health and Nutrition Examination Survey (NHANES) was
utilized that included almost 45,000 U.S. adults 20 years of age
or older. The average age was 46-47 years and approximately
half of the participants were women (almost all age ranges were
represented). These individuals were followed for up to 14.5
years.
Only 1-2% of the participants met all 7 of the health parameters.
Let me repeat that again, “Only 1-2% of the participants met all
7 of the health parameters.” Participants achieving 6 or more
metrics compared to 1 or fewer experienced a 51% reduction in
all-cause mortality, 76% reduction in cardiovascular mortality,
and 70% reduction in ischemic heart disease (IHD) mortality.
Achieving a higher number of cardiovascular health parameters
also appeared to be correlated with a lower risk for all-cancer
mortality (HEART HEALTHY IS ALL HEALTHY).
A lower risk of dying from all-causes including cardiovascular
disease was associated with a greater number of healthy
parameters, but again the actual numbers of individuals
meeting these criteria were so low it is scary. So, do you want
the best anti-aging secret in America that may reduce your risk
of dying from any cause? Use the following as your checklist
and see what you or your friends need to work on. Every time
you answer “yes” to any of the questions below you get to go out
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 11
and celebrate with a Pabst beer, light cheese and veggie pizza, and
buffalo wings for dessert (or they can be used as an appetizer…
don’t forget the celery sticks).
1. Do you avoid all tobacco products?
2. Are you physically active almost every day of the week?
3. Is your Body Mass Index (BMI) 25 or less? (Personally, I hate
this question because my BMI is 26 and I can run 7 miles a day
for 7 days a week and I can never get it in the “normal” range,
but who wants to be normal?)
4. Is your diet heart healthy (fruits/veggies/fiber/fish, and low
sodium)?
5. Is your total cholesterol equal to or less than 200 mg/dL?
6. Is your blood pressure equal to or less than 120/80?
7. Is your fasting blood glucose less than 100 mg/dL?
8. Do you exhibit extreme verve, happiness, and sheer joy when
someone starts fighting on a reality television show?
Okay, so I falsely added an 8th question! Gee, I wonder how many
of the 7 secrets to anti-aging above involve taking pills? If you
are able to achieve 1-4 or just get close to achieving these things, then
your pill count should be low. However, only 2% of Americans can
achieve these items listed above?! So, let me get this straight…over
50% of Americans take multivitamins or all sorts of pills regularly
but 2% cannot regularly follow lifestyle changes that can immediately
improve life expectancy? Wow! That is kind of like being obsessed
with removing “pink slime” in your meat, or worrying about bed
bugs and high fructose corn syrup, but at the same time you just love
to drive your car every single day to and from work really fast, on the
ice, in reverse, while also constantly texting and never wearing your
seat belt. Now that is some really weird stuff!
Look, I am not saying that the 7 metrics outlined by the American
Heart Association (AHA) are easy, and in fact they are a pain in
the _____(fill in your favorite dirty word like “rump”) to achieve,
which is why they need our regular attention. Wow, now that was
a serious statement!
226) Prescription drug abuse is arguably one of the fastest
growing medical problems in the U.S. So, be careful.
(Reference: Center for Disease Control, 2012; and Alam A, et al. Arch Intern
Med 2012;172:425-430.)
Bottom Line:
Remember this saying with any prescription drug or supplement:
“Start low, go slow, and you can reduce some side effects and save
some dough.” And, be careful with certain medications because it
is really easy to become addicted to some of them.
What else?
We need more studies that address long-term pain medication use
after a low-risk surgery in individuals that had not utilized these
medications previously. We just got a few of these studies and they
12
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
did not receive much attention, so let’s go ahead and give them the
attention they deserve my friends. This was a study from Ontario,
Canada that identified individuals 66 years and older that were
prescribed an opioid (serious pain medication) within 1 week
of the following procedures: TURP (prostate tissue removal for
non-cancerous enlarged prostate), cataract surgery, laparoscopic
cholecystectomy, or varicose vein stripping.
Short-stay surgery was analyzed among approximately 390,000
opioid-naГЇve adults. Patients receiving an opioid prescription
were 44% more likely to become long-term users versus those that
did not receive these medications. Patients that began utilizing
NSAIDs (non-steroidal anti-inflammatory drugs) within 7 days
of surgery were approximately 4 times more likely to become
long-term NSAID users versus those that did not receive such a
prescription. Additionally, many individuals initially receiving
a prescription of low-potency opioids became users of higher
potency opioids within 1-year of surgery. OUCH! Strong pain
relieving prescription drugs given immediately after a low-risk
surgical procedure occurs regularly in older individuals, and is
also correlated with long-term utilization of these medications.
I get calls monthly from some groups that really want me to give
a lecture about dietary supplements, and how concerning they
are, and how they can be abused and cause drug interactions….
blah, blah, blah! Yeah, I can talk about this, but some folks in the
medical profession are so obsessed with pointing a finger at all
of the dietary supplement concerns because they cannot see or
deal with all of the prescription drug issues (in my opinion - of
course my opinion - it is my volunteer column). This is called
“displacement” or “projection” in psychiatry, and it’s kind of like
yelling at someone or blaming someone for things even if they
were not at fault, because you are simply unhappy with your job
or situation.
In one of the latest national publications from the Center for
Disease Control (CDC), they confirmed that over 70 individuals
die daily in the U.S. from UNINTENTIONAL prescription drug
abuse mostly from pain and other commonly used medications.
That is crazy! Now, I am not implying that every person will
become addicted to the pain meds after a minor procedure, but I
am implying that thinking about “less is more” when it comes to
pills before and after a procedure is not a bad idea. And, 2 wrongs
do not make a right so, when it comes to utilizing opioids for
minor and routine procedures or talking about the dependence
on over the counter pain pills it is important to mention and
emphasize the “catch.” More pills have translated into more abuse
and more deaths! I know that this is a somewhat depressing part
of the column, but this is such a serious subject and problem that
it does not deserve a joke as an ending.
For individuals that are trying to reduce their pain pills by
occasionally using a supplement with a lower rate of side effects, I
offer you the next part of my column on SAM-e.
227) Why doesn’t the dietary supplement “SAM-e” get
more credit?
(Reference: Me, and feel free to do multiple searches on this supplement and
the research including meta-analysis to suggest it reduces arthritic pain, and
depression.)
Bottom Line:
SAM-e is getting a lot of research in the area of joint pain relief,
and improved mood (reduces depression), so why don’t more
doctors talk about it? I think they will start doing this very soon
(in fact at the time of this writing there was a small Harvard study
that showed a benefit in individuals with depression that were not
responding to regular medications).
What else?
A few weeks ago I gave a dietary supplement lecture in New
Orleans at the American Pharmacists Association Annual
(APhA) Meeting, and it was one of my favorite lectures to give
because no medical group in the world is more sensitive or
knowledgeable, in my opinion, about drug and supplement
side effects and interactions compared to pharmacists. Yet, you
might be surprised that I talked at length with the pharmacists
about the sad recent 2012 publication from the Center for Disease
Control (CDC) that I mentioned in the last part of the column,
which calculated the number of annual deaths in the U.S. from
unintentional prescription drug abuse. Therefore eliminating any
pill through lifestyle changes (if possible) gets me very excited.
However, I also get excited about any pill that seems to be effective
for a variety of conditions, and appears to have a low rate of
side effects, a low rate of dependency, is heart healthy, and may
ultimately reduce the number of pain pills used by an individual.
That would be groovy!
S-adenosylmethionine (SAM-e) is a compound present in every
cell of the human body. Its basic role is to make many other
compounds from head to toe work more efficiently, and perhaps
when the body does not generate enough SAM-e, then problems
can occur. Depressed individuals, for example, tend to carry low
blood and spinal fluid levels of SAM-e.
Researchers from Italy first documented the potential
antidepressant effects of SAM-e in the 1970s, and it has been a
prescription drug in that country since 1979.
It is interesting that almost every clinical trial of SAM-e by pill or
by intravenous (IV) or muscular injection route has found some
benefit for individuals with depression. Side effects have been
very uncommon, but can include nausea, and tummy aches (sorry
I had a flashback to when I was a little boy and I wanted to miss
school because I had a “tummy ache” and my dad would always
think I was lying and make me go to school and he was right - I
was lying).
The dosages of SAM-e used in the depression studies were 4001600 mg/day, but it appears that benefits have been observed
at a variety of dosages. Remember the Moyad saying with
supplements and prescription drugs “Start low, go slow, and
talk to the doctor and/or pharmacist you know before you even
start to spend any dough.” Hey, wait a second…that was a little
different from the last time I used that mantra in this column a
few hundred words ago. It is interesting to me that over the past
few decades while SAM-e was accumulating all of this clinical
evidence of efficacy and safety that St John’s Wort seemed to get
all the attention in terms of an effective over the counter antidepressant. And although St John’s Wort has some efficacy, the
“catch” with this herbal supplement has made it the negative
paradigm in the pharmacist and overall conventional medical
world. St John’s Wort not only has the potential for serious quality
control issues, but it may arguably reduce the efficacy of at least
50% of the available prescription drugs on the market. And, while
most prescription anti-depressants appear to have an enormous
negative impact on sexual function, it appears, from preliminary
studies, that SAM-e does NOT negatively impact sexual function.
Furthermore, a recent study from Harvard found that the
combination of traditional prescription anti-depressants drugs
with SAM-e appeared to result in greater efficacy for those with
difficult to treat depression compared with the prescription drug
alone! Still, never combine anything, including a prescription
anti-depressant with SAM-e until you and your doctor discuss the
positives and negatives that can occur when this happens (anyone
ever heard of “serotonin syndrome” or drug induced “mania”). In
other words, don’t take SAM-e and/or any prescription without
checking with the doctor that you trust the most in your world.
Now, ten years ago another notable medical journal review of
pain medications concluded that SAM-e was as effective as over
the counter Non-Steroidal Anti-inflammatory drugs (NSAIDs) in
terms of reducing pain and disability, and appears to be safer! In
fact, the real benefit for SAM-e is in the area of pain relief from
osteoarthritis. Americans love to consume over the counter pain
relievers, but they have resulted in a serious concern over acute
liver failure with excessive amounts of acetaminophen, especially
when combined with alcohol. Other NSAIDs that may cause
kidney dysfunction, now from another recent medical review
appear to increase the risk of cardiovascular issues and may also
negatively impact sexual function. Thus, SAM-e appears to be an
option and may show some effectiveness in reducing pain from
osteoarthritis at a dose of 200 mg three times daily, or even lower.
So, what other catches occur with SAM-e apart from the fact
that it also needs more long-term studies of efficacy and safety?
There have been concerns that SAM-e may increase blood
levels of “homocysteine,” which could theoretically increase the
risk of future cardiovascular and kidney problems, but recent
studies have not supported this concern. Yet, there is one issue
with SAM-e that no one can argue and that is the cost of this
supplement! Wow! It can be expensive, as much as 30-100 dollars
a month! Therefore, you need to shop around and look for lower
cost options and try it at the lowest dose after talking with your
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 13
doctor. SAM-e pills are not absorbed by the gastrointestinal
tract very well and this also needs to be improved. Regardless, it
is really amazing to me how far SAM-e has come in the medical
world, but at the same time just how far it needs to go in order to
get recognized as a legitimate option for those with some forms
of depression or pain. It is even being studied for liver disease
right now. So, I may have found one of the most under hyped
dietary supplements in the world that many medical journals
agree can be effective with and without conventional medicine.
However, remember the biggest side effect with this pill may be
a decrease in the size of your wallet or purse, so make sure you
compare prices and talk to your doctor/pharmacist. Finally, do
not forget that exercise and weight loss are cheap and also very
effective in reducing symptoms of depression and osteoarthritis
and can also improve your heart health! Yeahhh!!!
228) Pick the diet plan/fad that works for your personality
because most of them result in the same amount of
weight loss (and other healthy changes).
(Reference: de Souza RJ, et al. Am J Clin Nutr 2012.)
Bottom Line:
Caloric quantity has more impact on weight loss versus caloric
quality. Individuals experience equal weight loss benefits with a
variety of diet plans.
What else?
Weight loss can reduce body fat, but whether or not some diet
plans work better than others based on the nutrient intake is a
matter of debate that goes on and on and on---just like political
debates. So, researchers decided to determine whether calorie
restricted diets that place a different emphasis on fat, protein, or
carbohydrate impact total, deep belly fat; fat in and on the liver
and muscle mass.
A total of 424 individuals in a randomized trial of 4 weight loss
diets were measured for metabolic parameters at 6 months
and 2 years. Differences from the beginning of the study were
compared for the following diets:
1. low-fat, moderate-protein diet (20% fat, 15% protein,
and 65% carbohydrate),
2. low-fat, high-protein diet (20% fat, 25% protein,
and 55% carbohydrate),
3. high-fat, moderate-protein diet (40% fat, 15% protein,
and 45% carbohydrate), and
4. high-fat, high-protein diet (40% fat, 25% protein,
and 35% carbohydrate).
Each volunteer had a goal of reducing approximately 750
calories per day. The average age and BMI was 52 years and 33
(obese), respectively.
14
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
The average weight loss at 6-months was between 9-10
pounds and approximately 4.5 pounds of muscle mass with no
differences between the different groups. Individuals also lost 5
pounds of abdominal fat with no differences between the diet
groups. Individuals regained 40% of these original losses by
year 2 with no differences between the diets, and liver fat was
also reduced in all groups similarly. Basically, participants in
different dietary programs lost and regained the same amount
of weight over 2 years. There were also no differences between
groups in regards to body composition, abdominal or liver fat.
You want to hear a tired and really old line in medicine (apart
from “the doctor will be in to see you soon so wear this light and
beautiful gluteus maximus exposing gown while waiting”)…
”calories in = calories out.” Yet, this may really be true.
Reducing overall calories, rather than adding or subtracting a
specific macronutrient in the diet was the single most important
variable to determine fat loss in this incredible study. This is one
of the longest dietary trials in medical history to closely follow
individuals on different diet plans. What was learned was simple
and should be taught in every medical school today. Reducing
daily caloric intake up to 750 calories per day (even 100 calories
a day) allows for weight loss in a short period of time, regardless
of where the calories are specifically reduced in the diet. So,
reducing alcohol, bread(s) or fatty burgers (wait - don’t reduce
the fatty burgers) or juice, candy, chips or fries, etc…whatever
you are able to reduce is the right answer. Yet, being able to stick
with any diet plan beyond 6 months is so very, very difficult and
after 2 years almost half the weight that was lost was regained.
In other words, trying to micro-dissect your diet in order
to follow specific intakes of fat, protein and carbohydrate’s
over a very long period of time based on what you believe is
the best diet plan/method is about as futile as trying to get a
politician (democrat or republican) to stay away from Medicare
reimbursement cuts while at the same time doing nothing
for tort reform (oops - did I just say that….I guess I just did).
Basically diets are difficult and should be very flexible, but it is
really amazing that deep belly fat and liver fat were reduced with
weight loss, which again shows the destructive overall nature of
excessive fatty tissue on the internal organs and body, but at least
this can be reversed. Yes, weight loss is really, really hard, but
at least we now have great research to show that you have the
flexibility of picking where you want to reduce some of your
calories from your daily lives. For example, I am eating less
candy and less dessert and I thought of cutting back on beer and
popcorn, but then I thought nahhhhhh…can’t cut back on the
beer and popcorn in moderation because that would cause me
immeasurable pain and sorrow! Okay, I was being dramatic…
life is short…everything in moderation (I just made that up).
229) Protein supplementation needs to get more
attention for building muscle, reducing appetite and for
overall heart health?
(References: Teunissen-Beekman K FM, et al. Am J Clin Nutr 2012;95:966-971.)
Bottom Line:
Purchase a low calorie (about 100 calories per serving) soy, pea,
egg white or even whey protein isolate powder so that you can
use it several times a week to enhance your exercise workouts,
lose weight and become more heart healthy.
THAT IS ALL FOLKS!
See you in FALL, when I will write about many other serious
issues and give timeless advice in the next newsletter, such as
why it is never smart to take your first ice-skating or ski lesson
in the nude! Ouch and Yikes!
What else?
I used to love to make fun of the entire heavy steroid looking
muscle heads in the gym and especially their protein powders, but
could it be that I misjudged these folks? Yes! I was an idiot, because
I had not looked into the research in the past on protein powders
and now I have done this for the past few years. It turns out that
protein powders (just mix a scoop with water or a smoothie and it is
yummy) are now a wonderful part of most diet plans. I like to rotate
my protein powders every 2-3 months. So, I will use a high-protein
egg white powder (my favorite right now is the brand known as
“Jay Robb”…tastes great…and I have never met Jay Robb but it is
yummy) and then I will switch to a soy protein powder for a few
months and then perhaps a whey protein isolate. The bottom line
is there are few places in life that you can get such high amounts of
healthy protein (25 grams per serving) in a low calorie drink. Most
other protein sources such as protein bars, do NOT have this much
protein and if they do then they have a lot more calories.
Staying Active
With Urinary
Incontinence:
You Don’t Have
To Use Diapers
In fact, I believe that any man or women on LHRH treatment
or hormone therapy should actually ingest 1 serving of protein
powder daily to help maintain their muscle mass, because
reductions in testosterone or estrogen can be associated with
dramatic muscle loss in a short period of time. Researchers
have also learned that these protein powders can really suppress
your appetite (about 25-50 grams per day), so they should be a
part of most weight loss programs.
There is new research to suggest that protein powder may
reduce blood pressure! This was a randomized trial of 60
grams of mixed (20% pea, 20% soy, 30% egg, 30% milk-protein
isolate) protein powder per day compared to a similar amount
of carbohydrate. A total of 99 individuals participated in this
study. Systolic blood pressure and diastolic blood pressure was
4.9 and 2.7 mm Hg LOWER IN THE PROTEIN GROUP.
And for those of you that are curious I have decided to include
the average sources of protein from certain meats (for the most
part), which might also surprise you (based generally on one 3.5
ounce serving):
Chicken Breast = 32 grams of Protein (161 calories)
Dark Meat Chicken = 28 grams of Protein (200 calories)
Filet Mignon = 28 grams of Protein (214 calories)
Lamb Loin Roast = 21 grams of Protein (354 calories)
Tofu = 14 grams of Protein (144 calories)
Now, how attractive does 25 grams of protein from a protein
powder look when it only contains about 120 calories! Are you
feeling me on this one my friends?
Urinary Incontinence and Prostate Cancer
Urinary incontinence (UI) is a common side effect for men
who have undergone radiation, or have had surgery for prostate
cancer. If you are undergoing treatment for prostate cancer,
then you probably know that as a result you may develop urinary
incontinence, either permanently or temporarily.
Many of the men affected by incontinence can attribute their
bladder issues to prostate treatment. About half of the men
who undergo prostate removal will have some leakage; most
commonly in the first six months following surgery, however,
20% of men continue to experience leakage more than a year
after surgery.
Options for UI Management
While you are recovering from your prostate cancer treatment,
your doctor or other health professional will probably
recommend pelvic floor (Kegel) exercises that may eventually
improve your continence. You may be looking for ways to
manage your urine during this process, and after if needed.
But don’t be surprised if your doctor is not as knowledgeable
on new options for managing incontinence as you would
think. Unfortunately, doctors are inundated with treatment
information, with little time to review it all, as they are more
focused on acute medical conditions. Longer-term maintenance
and quality of life issues can be overlooked.
Products used for urinary incontinence include absorbent
pads and diapers, indwelling urethral (Foley) catheters, and
condom catheters. Infections and skin problems are common
complications with these products. These products can also
have social ramifications since they can be unpleasant and
unreliable. Men’s LibertyTM is a new way to immediately help
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 15
men to maintain their active lifestyles by giving men back their
freedom, mobility, confidence and masculine vitality.
Diapers and condom catheters are often not the best option for
men who wish to be active. Diapers may be uncomfortable and
bulky, cause odors, and may leak after a large void. Diapers
trap moisture against the skin causing Incontinence-Associated
Dermatitis (IAD). Diapers having high capacity absorbents
may reduce this problem; however, the skin is still subjected
to urine that is frequently acidic. The discomfort, odors, and
possibilities of skin breakdown and infections, make diapers an
undesirable option for many active men.
Condom catheters are not widely used because of a tendency to
pop off of the penis, and are also associated with skin breakdown
and Urinary Tract Infections (UTI). Some condom catheters
use an adhesive that is irritating to the skin.
For men to be active with urinary incontinence, a solution is
needed that is discrete and comfortable, seals reliably to the tip
of the penis, and keeps the skin clean and dry at all times.
The Men’s Liberty Solution
Men’s Liberty was created to get rid of unhealthy, unpleasant,
and uncomfortable catheters and absorbent pads and diapers.
It was created to give men and caregivers freedom and mobility
(and has several patents and patents pending). Men’s Liberty is
the discrete, no-fuss option, especially for active men.
Men’s Liberty is a completely external and non-invasive
continence system that seals directly to the tip of the penis with
skin friendly hydrocolloid adhesive. Men’s Liberty directs all the
urine away from the body into a convenient collection pouch.
The skin stays completely clean and dry at all times, and Men’s
Liberty can be worn for more than 24 hours with no leakage.
“Men’s Liberty is applied to the tip of the anatomy with
hydrocolloid and then sealed with a second wrap.”
16
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
“Men’s Liberty is a Complete Urine Collection System.”
Men’s Liberty ends dependency on adult diapers, pads,
and condom catheters, making an embarrassing problem
insignificant and dramatically reducing, if not eliminating, the
chance of infection (after more than one million applications, no
UTIs were reported that are attributable to Men’s Liberty).
Men’s Liberty is Designed to Keep You Active
To keep you active, Men’s Liberty is designed to work with your
specific needs and has many features to assure reliability when
you need it. Men’s Liberty was designed as a complete system
under the guidance of medical professionals that understand
the physiological requirements of various conditions including
those that are associated with treatments for prostate cancer.
• Men’s Liberty is quick and easy to apply, important when
you are on the go.
• Men’s Liberty was designed by a clinical team to
accommodate all male anatomy, including large, small,
retracted, and uncircumcised.
• The adhesive that secures the Men’s Liberty system to your
penis is a moisture compatible hydrocolloid material and
will work even as you perspire.
• The urine collection pouch that is part of the Men’s Liberty
system is comfortable and discrete - small enough to fit
within your pants. If you want to connect to a urinary
leg bag, the pouch has an easy connection. A supporter
accessory is available if you prefer.
• The system has a vent that assures urine flows easily into
the pouch, and the pouch contains a valve that prevents
urine from flowing back even when you are active.
• Men’s Liberty can be removed instantly when you are
ready, with the optional FreeDermTM adhesive remover.
Men’s Liberty and Sports
Men’s Liberty is now a sponsor for adaptive athletes, who stay
active by using sports equipment designed to work with their
disabilities. Hydration and fluid management are of critical
importance for athletes; the only effective way to compete
for some men is with Men’s Liberty. With a totally external
device men can continue to enjoy sports without the bulk and
difficulties that present with diapers and condom catheters.
Adaptive athletes using Men’s Liberty are active in wheelchair
games and races, fishing, hunting, downhill skiing, golf,
kayaking, table tennis championships, horseback riding and
much more. These athletes claim that they are able to continue
their active lifestyle as a result of using Men’s Liberty. Wounded
heroes who served us in the military and now stay active in
sports are also benefiting from Men’s Liberty.
Trying Men’s Liberty
Men’s Liberty is covered by Medicare, Medicaid, Workers
Compensation, the VA and most private insurance plans. Most
users pay little to nothing out of pocket.
A free starter pack is available that includes three samples for
men to try and experience the benefits of Men’s Liberty. A
Customer Care team is available to answer all your questions
and help you have the best chance of getting the results you
desire from Men’s Liberty.
For more information on Men’s Liberty and male bladder
management, call the Men’s Liberty team at (800) 814-3174,
email: CustomerCare@MensLiberty.com, or visit online at
www.MensLiberty.com.
A STRANGE
PLACE
part
V
AN INFORMATION GUIDE TO PROSTATE CANCER
Notice of CopyrightВ© T. R. Herbert 2010
This booklet is being printed in a multi-part series. Part 1 began June 2011, Volume 27,
Number 2. This is part 5 in the series. We will continue with part 6 in the September 2012
(Volume 28, Number 3) issue.
Terry Herbert, the author of this booklet, has no medical training. He was diagnosed
as having prostate cancer in August 1996 and has learned something about the subject
since then. In 1998, with colleagues Gregg and Kerry Morrison he established a website
- YANA- You Are Not Alone Now at www.yananow.net. The stated mission of the site,
which is still active, is:
“To provide comfort to any man diagnosed with prostate cancer, to offer thoughtful
support to him and his family and to help them to decide how best to deal with the
diagnosis by providing them with and guiding them to suitable information, being
mindful at all times that it is the individual’s ultimate choice; that the path he decides to
follow is his own and that of his family, based on his particular circumstances.”
Terry Herbert has produced this booklet. It represents a significant input of the knowledge,
skills and time of Terry Herbert. It is regarded as intellectual property owned by Terry
Herbert and is subject to copyright.
Acknowledgement is made, and thanks given, to Donna Pogliano; members of the
Prostate Support Action (PSA) Group and the YANA - You Are Not Alone Now website
and members of my family who assisted in the final editing of this booklet. And to
members of the YANA site for their generous donations that made this edition possible.
This document is supplied free of charge to those who need it. A donation will ensure that
more copies are made.
Index:
A Continuation Of Treatment Choices
Cryotherapy
High Intensity Focused Ultrasound (Hifu)
Active Surveillance (Often Referred To As Watchful Waiting [Ww])
(To be continued in the next issue beginning with Beyond Treatment
– The Plains Of Recovery)
CRYOTHERAPY: This procedure uses probes to freeze the
gland. The targeted prostate tissue is then destroyed by the very
rapid thawing process which ruptures the cell membranes.
The probes are placed through the perineal skin - between
the scrotum and anus - like the tubes for brachytherapy. They
are guided using transrectal ultrasound which is also used to
monitor the freezing process in real time. It is unusual for
fewer than three probes to be placed; additional probes may
be placed to allow for adequate freezing of more extensive
disease. Incontinence levels are kept low by warm liquid
being circulated in the urethra during the procedure.
When this procedure was first used, the entire gland was
destroyed, which led to a very high incidence of erectile
dysfunction - almost 100% of men were impotent according
to some studies. Later developmaents have seen the
development of focused cryotherapy, which destroys only
identified tumors and the healthy cells in the immediate
vicinity of the tumor, leaving some or all of the erectile
nerves untouched and resulting in levels of ED that are
comparable with those resulting from other treatments. It
can be difficult to pinpoint the position of small tumors. This
usually involved a mapping biopsy using a large number of
needles; as a rule of thumb the volume of the gland + 20 - up
to a potential maximum of 100 needles. This type of biopsy is
usually undertaken under a general anesthetic.
One advantage this form of treatment has is that it can be
repeated and it can be used in suitable cases as a salvage
procedure for other failed treatments, notably radiation.
HIGH INTENSITY FOCUSED ULTRASOUND (HIFU):
This procedure was developed in China and used for liver
and pancreatic cancers, but was not used initially for prostate
cancer. Subsequently several European countries, notably
France, Germany and Belgium started to treat men with
prostate cancer. Basically the targeted prostate and tumor
cells are cooked to death. The focused sound energy raises the
temperature to around 140 degrees Fahrenheit (60 degrees
Celsius), killing the cells in about one second. The ultrasound
beam must travel through continuous tissue or fluid to the
tumor site because the energy cannot be focused through gas
or bone. By targeting tumor cells precisely, theoretically the
tumor can be destroyed with minimum collateral damage.
Like cryotherapy one of the immediate pre-treatment issues
is how to identify the precise location of the cancerous cells.
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 17
HIFU is still regarded as experimental in a number of
countries and has not yet been approved for prostate cancer
by the FDA in the U.S.A. although trials are being carried out
there. There have been alarming reports of bladder damage
creating severe urinary problems.
It is clear that experience with the equipment used for this
therapy is even more important than in other therapies. An
unskilled practitioner can do a great deal of damage very
quickly.
ACTIVE SURVEILLANCE: This option is still often
referred to as WW (Watchful Waiting) although the terms
have different meanings. In the past Watchful Waiting meant
no action was undertaken unless the disease was seen to
progress. Men choosing Active Surveillance are monitored
closely and will often use a variety of non-conventional or
alternative treatments to manage the progression of the
disease.
Dr Jon Oppenheimer, a leading pathologist in the U.S.A. is
on record as saying:
“For the vast majority of men with a recent diagnosis of
prostate cancer the most important question is not what
treatment is needed, but whether any treatment at all is
required. Active surveillance is the logical choice for most
men (and the families that love them) to make.”
The rationale for this statement is that prostate cancer is
what is termed an “indolent” disease in most cases, because
it progresses so slowly it may never be a threat to life. Many
men choosing Active Surveillance believe by taking a
proactive stance they can harness their immune system to
either halt the progress of the disease or possibly even cause
it to regress.
Prime candidates for this option are those who have been
diagnosed with an insignificant tumor or very low risk
disease. There are various definitions of these terms, but
broadly speaking they are similar to the one established by
Johns Hopkins University School of Medicine in the U.S.,
where the definition of an insignificant tumor was established
some years ago as one with the following characteristics:
• Non palpable - the examining doctor would not feel
anything when carrying out the DRE (Digital Rectal
Examination)
• Stage T1c - the tumor is discovered in the course of a
biopsy following an elevated PSA test where there are no
other symptoms
• Free PSA - the percentage of free PSA should be 15% or
greater
• Gleason Score - less than 3 + 4 = 7 or as some practitioners
have it, 7 or less
18
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
• Size - less than three needle cores positive with none
greater than 50% tumor. (In this definition it is assumed
that a 12 needle biopsy is used)
The latest guidelines issued by the National Comprehensive
Cancer Network (NCCNВ®) following the codified changes
to the Gleason grading system in January 2009 has this
definition of very low risk disease:
• Clinical Stage T1-T2a - the examining doctor felt
nothing on DRE or felt something on one side of the
gland only
• Gleason Score 6 - the lowest score on the current range
• PSA less than 10 ng/ml
• Size - 3 positive needles or less with 50% or less positive
material in each core
• PSA density - less than 0.15 ng/ml/gm
Old studies have shown the majority of men with a diagnosis
similar to these will not have a life-threatening progression
of the disease for many years. Current studies demonstrate
that there is negligible additional risk for suitable men in
undertaking Active Surveillance.
The problem for any man considering this option is the
uncertainty of the diagnostic process, which is more art than
science. It is not possible to identify, with absolute certainty,
which tumors are indolent (the kitty cats) and which are
aggressive (the tigers) or just where they fit in the range of
this disease. There are good indicators: The ones listed above
indicate disease that is most likely indolent; on the other
hand PSA doubling times measured in months or weeks,
high Gleason Scores (8 – 10), PSA over 20 ng/ml, late stage
disease - stages T3 and T4 all indicate a disease that requires
early attention. Indolent disease can often be treated like a
chronic illness.
For many men choosing this course, the essence of Active
Surveillance is a belief in the mind/body continuum. The aim
is to maintain the immune system in good condition to deal
with the tumor. Since there are very few studies to guide men
in this endeavor, and the medical professionals are often illinformed on nutritional matters and similar issues, there is a
tendency for each man to develop his own unique program.
Most of the programs for which there is anecdotal support
include the following elements:
• Stress reduction: Stress is commonly regarded as one
of the most universal causes of damage to the immune
system. Stress reduction can be accomplished using
activities such as meditation, visualization or yoga.
• Exercise: Moderate amounts of exercise are essential.
Usually, subject to the fitness of the man, he is
recommended to exercise at least three days a week at a
level where the pulse rate is raised and sweat is formed.
• Changes in diet: This subject is covered in a little
more depth in the section titled Plains of Recovery,
but essentially, the aim is to attain a vegetarian diet or
better still a vegan diet. Red meat and dairy products are
regarded as bad: fresh vegetables and fruit are regarded as
good. Smoking should, of course, be stopped, as should
consumption of alcohol, although small quantities of
wine, especially red wine, are thought to be beneficial.
Consumption of coffee, animal fats, fried foods and
sugar should be kept to a minimum.
• Weight loss: There is a clear connection between illness
and obesity. Although following the steps above should
lead to weight loss, this should also be incorporated as
one of the aims of any successful program.
Successful Active Surveillance management should see a
stabilizing or even a reduction in PSA levels, and this is the
primary measure of success. Because of the vagaries of PSA
counts, this should not however be the only measure. There
should also be an annual DRE (Digital Rectal Examination)
and, some recommend, an annual or biennial biopsy. In
considering this latter test, some thought should always
be given to the potential for side effects from biopsy. A
continuous rise in PSA or a positive DRE would be the
trigger to contemplate further, conventional treatment.
Many men - more than 20% in one study - who have chosen
Active Surveillance have negative biopsy results on repeat
biopsy. This does not necessarily mean that there are no
longer cancer cells in the gland, because the biopsy process
is literally �hit and miss’ but it does imply that there has been
little or no significant growth in the tumor.
The side effects of a successful Active Surveillance program
are all positive since the enhanced immune system will
generally result in better health all round.
It is often difficult to deal with the uncertainty associated
with Active Surveillance. This is often seen to be greater
than the uncertainty of those who have had conventional
treatment. However in three studies it has been found
that essentially, if men are �worriers’ they have similar
levels of concern whatever the path they choose. Those who
are more phlegmatic accept the uncertainty more easily.
Anyone embarking on Active Surveillance will need
determination to continue. The medical profession along with
well-meaning friends and relatives often create a good deal of
pressure to �do something.’ This leads many men to abandon
Active Surveillance and opt for conventional treatment even
if there is no significant change in the diagnostic pointers.
LETTERS TO THE EDITOR
Mr. Profit,
A short note to thank you for returning my phone
call and for the support and information.
I was surprised to receive Dr. Moyad’s book
“Beyond Hormone Therapy.” I gained more
information in reading his book than I have in the
past 17 yrs. since being diagnosed with prostate
cancer.
Keep up the good work.
Sincerely,
JB
Dear Mr. Profit:
I wanted to personally thank you as a beneficiary
of your objective, unbiased advice over the years
that enabled me to make the right choice for my
prostate cancer.
You are doing a tremendous service for so many
men, so often caught in the throes of conflicting
advice by self-interested parties.
Please let me thank you on behalf of them as well
as myself. Yours is an invaluable service.
Please pass on news of the enclosed, if you wish.
Though it’s not in your field, it is helping needy
people – those who are hungry. And it costs
nothing for any anti-hunger agency to share in our
money and use it as spur to other donations, too
(www.feinsteinfoundation.org).
My best wishes to you for the New Year, Mr. Profit.
You’ve done and are continuing to do invaluable
good for countless men.
With admiration,
Sincerely yours,
ASF
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 19
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of Urology,
of Urology,
The Mayo
TheClinic
Mayo Clinic
John Mulhall,
John Mulhall,
MD MD
Preventing
Preventing
Treatment-Related
Treatment-Related
Side Effects
Side Effects
Director,
Director,
Male Sexual
Male and
Sexual
Reproductive
and Reproductive
Medicine
Medicine
Program,
Program,
Memorial
Memorial
Sloan-Kettering
Sloan-Kettering
Cancer Cancer
Center Center
Lori Buckley,
Lori Buckley,
PsyD PsyD
Issues ofIssues
Intimacy
of Intimacy
Therapist,
Therapist,
Dr. LoriDr.
Buckley
Lori Buckley
& Associates
& Associates
SUNDAY,
SUNDAY,
SEPTEMBER
SEPTEMBER
9, 2012
9, 2012
Mark Moyad,
Mark Moyad,
MD MD
Saturday
Saturday
review, review,
Q&A Q&A
Senior Research
Senior Research
Associate,
Associate,
University
University
of Michigan
of Michigan
MedicalMedical
School School
8 AM to
8 AM
9 AMto 9 AM
Mark Scholz,
Mark Scholz,
MD MD
MedicalMedical
Director,
Director,
ProstateProstate
Oncology
Oncology
Specialists
Specialists
ASK THE
ASKEXPERTS
THE EXPERTS
MichaelMichael
Steinberg,
Steinberg,
MD MD
Radiation
Radiation
Chair ofChair
Radiation
of Radiation
Oncology,
Oncology,
UCLA UCLA
StephenStephen
Strum, Strum,
MD MD
Hormone
Hormone
Blockade
Blockade
MedicalMedical
Oncologist
Oncologist
RichardRichard
Lam, MD
Lam, MD
Chemotherapy
Chemotherapy
Duke Bahn,
DukeMD
Bahn, MD
Active Surveillance
Active Surveillance
&
&
MedicalMedical
Director,
Director,
ProstateProstate
InstituteInstitute
of America
of America
Focal Therapy
Focal Therapy
David Heber,
David Heber,
MD MD
Nutrition
Nutrition
and Fitness
and Fitness
CharlesCharles
“Snuffy”
“Snuffy”
Myers, Myers,
MD MD
Hormone
Hormone
TherapyTherapy
EugeneEugene
Kwon, MD
Kwon, MD
SurgerySurgery
*AGENDA
*AGENDA
& FACULTY
& FACULTY
SUBJECT
SUBJECT
TO CHANGE.
TO CHANGE.
3
20
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
3
ACKNOWLEDGEMENTS OF CONTRIBUTIONS
January 1, 2012 Through March 31, 2012
(YOUR NAME WILL APPEAR BELOW IF WE DEPOSITED YOUR DONATION BETWEEN THE ABOVE DATES)
Memorial Contributions
In Loving Memory of Lloyd J Ney, Sr.
Founder of PAACT, INC., Grand Rapids, MI
Dr. Bob Leibowitz
In Loving Memory of Lloyd
Dennis Stuhr
Stan House
Norman Smith
In Loving Memory of Dr. Thomas Scott Truitt, DMD - Colonel U.S. Army (Ret)
Jim Thomson
Ronald & Norma Campbell
The Hendrix Family
Earl & Linda McCallum
Richard & Susan Frushour
Carl & Linda Strojan
David Hudson, DMD, PA
Jeanne M Warner
Greg & Kathy Peterson
Dr. Charles & Karen Wyont
Pamela Grickis
Bradley Plumbing & Heating, Inc.
Bill & Joyce Hardy
John & Eda Morelli
Michael & Sandy Power
Ronald E Toole, DMD
Russ & Jean Schwalbert
Dan & Julie Overall
Frances R Boyce
Larry & Sheri DeWitt
Joseph Shappell
Brent Richards
Thong & Phuong-Nhi Hang
Gregory & Lynn Hall
Nancy Sjostrom
Savannah River Banking Company
Carolyn Apperson
John & Roberta Knox
Michael & Margaret Rollins
Jack R Miller
Steve & Sherry Hansel
Aiken County Dental Society
Friends at Hutson-Etherredge Companies
In Loving Memory of Mary Sandra Guyer
Richard Kolkka
In Loving Memory of Dr. David Todd
In Loving Memory of My Brother Pat
John Learman
Michael P Springer, Jr.
In Loving Memory of George Johnston
Wayne & Colette Hedien
In Loving Memory of Captain David Cronin
In Loving Memory of Lawrence L Brown
United Airlines Flight 811
Barbara Brown
Jan Driessen
In Loving Memory of Julius Sirowitz
In Loving Memory of Fred Williams
Charlene Sirowitz
David Williams
In Loving Memory of Robert N Greene
In Loving Memory of Carl Hirschfeld
Dorcas P Greene
Peter Manes
In Loving Memory of Luella Engelke
In Loving Memory of My Father, John Shappell
Carol A Arnold
Joseph Shappell
In Honor of My Dad Roy E Flake
Terri O’Neill
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 21
Contributions
($1,000 and Above)
Contributions
($500 to $999)
Field, Elvin
Patron Membership
($100 to $499)
Aaronson, Rev. David
Agan, Mike
Ali, Earl
Amir, Raymond
Anonymous
Ayer, Donald
Baker, Charlie
Basta, George
Billings, Robert
Brown, Arthur
Byrne, Donald
Christman, Ronald
Clauser, Ray
Clyma, Frank
Coker, Dennis
Cooley, Dave
Cox, Laurence
Curry, A.M.
Dubin, Carol
Ferrier, Ray
Gaudioso, Robert
Goodland, Robert
Gould, Gerald
Grissom, Gary
Heffron, Dr. Chuck
Hennessey, Charles
Horneffer, Harold
House, Stanley
Hudspeth, Jack
Jezek, Ray
Johnson, Philip
Jones, Rex
Keppel, Paul
Korstanje, John
Lane, Moses
Lomax, Art
Magarian, Gerald
Manheim, Stewart
McIlwain, Arthur
McIntee, F.P.
Parker, Ted
Pausig, Dr. Ronald
Preston, Fred
Rauscher, John
Schwan, David
Sharp, Ben
Shimer, Alan
Snyder, William
Strite, Dan
Suri, Hira
Swisher, Robert
22
Taylor, Conway
Walker, Gil
Wencley, Stan
Wilkes, James
Wilson, David
PAACT Membership
($50 to $99)
Allison, Richard
Anderson, James
Anderson, Joseph
Anonymous
Bennett, Edward
Berry, Jean
Biondo, Vince
Blake, Charles
Blaser, Donald
Block, Louis
Bohn, Paul
Borer, Paul
Bronstein, David
Brown, Charles
Buck, Tom
Burroughs, John
Carson, Robert
Constance, Donald
Cooley, Jack
Delatush, Dr. George
Dennis, Max
Dorr, Howard
Dugger, Richard
Dunning, Larry
Eiken, Erling
English, Ross
Fields, Karen
Flake, Roy
Fletcher, Herbert
Fuchs, Vale
Garrison, Richard
Gerassi, John
Greenblatt, Elias
Gruenwald, Edward
Guenther, Steven
Gunther, Norman
Hall, George
Hallenbeck, Richard
Hamilton, David
Harper, Dennis
Hays, Henry
Hellings, David
Herman, James
Hertel, Robert
Hiob, Manfred
Howard, Ted
Howell, Marvin
Huang, Donald
Juday, Bernard
Kaufman, Stanley
Keck, Robert
Kelly, Peter
Kerkorian, Charles
Kim, Iksu
Kocher, Robert
Kramer, Dr. Ron
Kusnirik, Robert
La Porta, Nicholas
Lamb, Sydney
Laubach, Robert
Lilley, Richard
Lind, George
Loomer, F.D.
Lustig, David
Luttrell, Robert
Macy, Harry
Magley, Jack
Mallon, John
Mann, Donald
Marino, Edward
Marsted, P Severin
Mather, Hal
McCormick, James
McGovern, Robert
McGowan, John
McLeod, Douglas
Meetze, Jack
Michaels, Jeremy
Milstead, John
Mitchler, Lawrence
Mrukowski, William
Murley, Windsor
Myers, Hal
Newstrom, Wayne
Nord, Arlo
Nystrom, Donald
Oppenheim, Robert
Owen, Robert
Palmer, L.W.
Pfizer Foundation
Matching Gifts
Piehl, R.A.
Rapattoni, Salvatore
Rigby, Edward
Roedl, Douglas
Ruebsamen, Neil
San Jose Support Group
Sanford, Gus
Sarna, Walter
Serruto, Roy
Shaw, Dr. Roger
Shere, Charles
Singer, Arthur
Sisson, Victor
Spangrude, George
Steinhauser, Rudolph
Stephens, Robert
Stoney, Gordon
Strack, Bob
Sugar, Dr. Max
Tehan, George
Thomas, Clarence
Prostate Cancer Communication / JUNE 2012 • www.paactusa.org
Thompson, Walter
Travis, John
Wagner, Albert
Wakely, William
Watterson, John
Weiss, Franklyn
Whitten, Robert
Wilson, Bill
Wilson, C Vaughn
Wright, Raymond
Miscellaneous Contributions
(less than $50)
Anonymous
Bailey, Charles
Baker, John
Blundell, James
Bonecutter, Roger
Braun, Irwin
Bruhns, Frank
Burger, Eugene
Burkett, Charles
Carrano, Arthur
Clark, Earl
Coddington, Steele
Colier, Philip
Cunningham. Patrick
Daniels, Susan
Denney, James
Dunn, Joseph
Eagle, John
Eisenberg, Albert
Fancher, Duke
Fusco, Joseph
Givone, Dr. William
Harvey, Andrew
Henson, Keith
Hill, Robert
Hovey, Roy
Hyatt, Stuart
Iannaccone, Louis
Jackson, Lesley
Kennedy, James
Kintner, George
Krejci, Dr. John
Kubecka, Paul
Lindsey, Jim
Litten, James
Loeffler, Tony
Matus, Richard
May, Don
McCann, Alfred
Montgomery, George
Patterson, Philip
Pitt, John
Pittelli, Rudy
Schlappi, Larry
Segal, Arnie
Siegelman, Philip
Stanley, William
Starr, Dr. Robert
Stockinger, Barry
Vanni, M.O.
Vaughan, Jr., W.J.
Villoch, Jorge
Wendt, Michael
Youngberg, Ed
Contributions by State
& Province
Alabama...................1
Arizona.....................3
California...............45
Colorado...................6
Connecticut..............1
Florida....................35
Georgia.....................4
Hawaii......................1
Idaho........................1
Illinois....................11
Indiana......................4
Iowa.........................3
Kansas......................1
Kentucky..................1
Louisiana.................1
Maine.......................1
Maryland..................2
Massachusetts..........1
Michigan................14
Minnesota.................2
Missouri...................2
Montana...................1
Nebraska..................2
Nevada.....................3
New Hampshire.......2
New Jersey.............15
New Mexico.............3
New York...............15
N Carolina..............10
Ohio.........................6
Oklahoma.................1
Oregon.....................9
Pennsylvania............6
S Carolina...............18
Tennessee.................4
Texas......................11
Utah.........................2
Vermont....................1
Virginia.....................2
Washington..............5
West Virginia............2
Wisconsin.................5
Wyoming..................3
Australia...................2
Canada......................1
Denmark...................1
France.......................1
Saudi Arabia.............1
Financial Summary Report
h 31, 3012)
(January 1, 2012 through Marc
FUND
GENERAL
1,645,719.19
2011
31,
er
emb
Dec
d
Han
on
e
anc
Bal
REVENUES RECEIVED Membership Contributions
Memorial Income
Trusts & Bequests
Investment Income
Reimbursed Expenses
Total Revenues
21,366.45
2,055.00
2,267.97
14,537.88
43.55
5
70.8
40,2
Revenues
Total Balance on Hand and
EXPENDITURESInvestment Withholding
Employee Wages Payroll Taxes
ation)
Insurance (Health, House, Workman’s Compens
Outside Services, Labor
Rent
Meals, Motel, and Transportation
Auto Expense
Printing
Postage and Delivery
Telephone
Service Plans/Licenses & Permits
Program Expense-Conference Exhibit Fees
Office and Computer Supplies Utilities - Refuse
Repairs (Building, Equipment)
Miscellaneous
Total Expenditures
Balance on Hand March 31, 2012
Assets:
Checking Account
Petty Cash
Savings Account
Certificates of Deposit, Stocks, and Bonds
Money Market Funds
Equipment
Net Assets:
Foundation Fund Balance: 1,685,990.04
0.00
32,868.12
3,091.01
11,035.50
450.00
3,900.00
1,087.29
0.00
6,118.85
6,881.03
978.74
2,839.14
0.00
479.20
0.00
0.00
2.62
69,731.50
1,616,258.54
29,714.25
50.00
29.63
1,233,005.72
59,205.01
9,144.92
1,331,149.53
261,651.40
www.paactusa.org • JUNE 2012 / Prostate Cancer Communication 23
ADDRESS SERVICE REQUESTED
PAACT, Inc.
(PATIENT ADVOCATES FOR ADVANCED
CANCER TREATMENTS, INC.)
1143 Parmelee NW Grand Rapids, MI 49504
Phone: (616) 453-1477
Fax: (616) 453-1846
paact@paactusa.org
www.paactusa.org
NONPROFIT ORG
U.S. POSTAGE
PAID
GRAND RAPIDS, MI
PERMIT NO. 875
Join Us
on Facebook!
P A A C T M embership F orm
Name:
Birthdate:
/
/
Address:
City:
St/Province:
Telephone HM:
WK:
Postal Code:
Fax:
E-Mail:
Other:
A nnual M embership C lassification
c Patient................................................. $55
c Donor................................................ $500
c Advocate............................................. $55
c Sponsor...........................................$1000
c Professional...................................... $100
c Corporate........................................$5000
c Other...................................... $________.
c Anonymous...........................$________
c Include me as a PAACT member, although I currently cannot contribute
Tribute gifts support the daily operations of PAACT, Inc., by furnishing PC patients, doctors and advocates with the latest
information available on the methods of detection, diagnostic procedures, evaluation and treatments for prostate cancer. We
also participate in matching gift programs and United Way. For more information contact us at (616) 453-1477.
c Check Enclosed c Charge to my credit card (below): c MC c VISA c Discover c American Express
Enclosed is $ ________________________________________________, In memory of Lloyd J. Ney, Sr.
Enclosed is $ ________________________________________________, for PAACT’s general operation expenses.
Enclosed is $ ________________________________________________, I wish to remain anonymous.
In Memory of ___________________________________________________________________________________________
Please send acknowledgement card to:
Name __________________________________________________________________________________________________
Address_________________________________________________________________________________________________
City_________________________________________________State____________________Zip________________________
Account Number: ________________________________________________ Amount $ _______________________________
Signature: ______________________________________________________Expiration Date: ___________________________

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