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New
Clinical Trials For Prostate Cancer: Vitamin D
September 25, 2008
Prostate
Forum is pleased to announce
Dr. Myers’ new Phase II clinical trial on treating slow-growing
recurrent prostate cancer with Vitamin D3, run by the Foundation
for Cancer Research and Education (FCRE).
FCRE has three other pivotal clinical trials slated for the next
few years that hope to bring new insight to the prostate cancer
community.
“As a prostate cancer survivor, I’m very interested
in testing the efficacy of supplements and other non-toxic agents
that may impact prostate cancer growth,” says Dr. Myers. “In
my clinic, I began to see how dramatic an impact Vitamin D3 can
have on men whose cancers had relapsed after radical prostatectomy,
radiation therapy, or both; I soon realized a more in-depth analysis
was in order.”
FCRE, the foundation funding the trial, notes that they’re
still recruiting patients and that the following men are eligible:
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Those who have prostate cancers that have
relapsed after radical prostatectomy, radiation therapy,
or both and have PSA doubling time of 9 or more months; |
| • |
Those whose PSAs are less than 15 ng/ml
when they enter the trial; |
| • |
Those who have no evidence of metastatic prostate cancer
by CT or bone scan; |
| • |
Those who the investigators feel
are likely to be able to adhere to the protocol. |
Men who aren’t eligible are those:
| • |
On hormone or chemotherapy or other systemic
therapy; |
| • |
With abnormal creatinine |
| • |
With abnormal serum or urine calcium |
| • |
With a history of renal calculi |
| • |
With another medical disease likely
to limit their survival to less than 5 years |
| • |
With celiac disease or other causes
of fat malabsorption. |
| • |
With known abnormalities in calcium
metabolism, such as hyper- and hypoparathyroidism |
During the course of the trial, Dr. Myers aims to adjust each
patient’s oral dose of vitamin D3 to maintain serum 25-hydroxyvitamin
D3 levels in the high end of the normal range, or between 60-100ng/ml.
To that end, Myers will measure monthly for the first six months
each man’s PSA, testosterone, dihydrotestosterone, calcidiol,
calcitriol, fasting serum parathyroid hormone, serum calcium,
serum phosphate, urine calcium/creatinine ratio, BUN and creatinine.
During the second six months, Myers will make same measurements
every 2 months. After the first 12 months, these tests will be
performed every 3 months as long as the patient continues to
participate in the study.
There are some restrictions on what patients can do while they’re
participating, however. They can’t use any other prostate cancer
treatment. They can’t take any drugs or supplements reported
to slow PSA doubling times. And they’re prohibited from following
a number of other treatments.
For more information about the trial, contact FCRE’s Director
of Clinical Research, Joanne Mahanes via email at info@prostateforum.com or by calling 434-220-4539.
“Part of my practice has also ways been testing the efficacy
of dietary supplements as they pertain to prostate cancer,” Myers
says. “The Vitamin D trial is meant to not only solidify
this in a traceable way but to also provide certain patients
with the knowledge that they can be active participants in their
own treatment by adopting simple practices that may not only
impact their prostate cancer but, considering the body of information
available, their general health as well.” |
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