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Medical Forum / Diseases and Disorders / Prostate Cancer / March 2008

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Phase II Study Recruiting: Treatment of Slow-Growing Recurrent     Prostate Cancer with Vitamin D3

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ron - 12 Mar 2008 15:23 GMT
The following information was posted on another PCa newsgroup with the
request that it be shared...ron

------------------------------------------------------------------------------------------------------------

Phase II Study:  Treatment of Slow-Growing Recurrent Prostate Cancer
with Vitamin D3

We are initiating a new clinical trial testing the ability of vitamin
D3 to slow or arrest progression of prostate cancer recurrent after
surgery or radiation.

Prostate cancer is a very variable disease that can range from a
disease that is rapidly lethal to one that progresses so slowly that
it poses little risk to a patient's health. This issue has come to the
fore in several
recent studies of prostate cancer recurrent after radical
prostatectomy or radiation. These studies have shown that patients
with a PSA doubling time slower than 9 months have a 10-year mortality
of 15% or less. If the patient recurred more than 3 years after
initial treatment, 10-year mortality was typically 5% or less. In
2005, a pilot study reported that vitamin D3 supplementation arrested
progression in 9 out of 15 such patients. In this
study, patients were given 2000 IU of vitamin D3. The promise of this
paper is that cancer progression in these patients may be slowed or
arrested with a treatment with low risk and expense compared with most
cancer treatments.

Since people get vitamin D3 from the sun as well as pills, we think it
will be better to target a specific blood level rather than a fixed
dose.  In our study, we will target vitamin D3 blood levels typically
seen in young people
with daily intense sun exposure.

Study participants will be men age 40 years and older that fall into
either of these good prognosis groups:

(1)   Those who have a PSA doubling time of 9 months to 11.9 months
and

(2)   Those who have a PSA doubling time equal to or greater than 12
months

Additionally, the following criteria must be met for consideration:

*       Diagnosis of prostate cancer
*       At relapse after radical prostatectomy or radiation therapy, a
PSA doubling time of 9 or more months
*       PSA at entry must be less than 15 ng/ml
*       No evidence of metastatic prostate cancer by CT or bone scan
*       Subject must be assessed by the investigator as likely to be
able to adhere to protocol

Inquiries may be directed to Joanne Mahanes, Director of Clinical
Research,
via email at jm.fcre@earthlink.net or by calling 434-220-4539.

Sincerely,
Charles "Snuffy" Myers, M.D.
Just - 12 Mar 2008 20:43 GMT
Ron,

A few questions:
- Which is the organisation running this Phase II study?
- Do you have a link for this?
- Do you know which will be the D3 level targeted?  Quote: "we think
it will be better to target a specific blood level rather than a fixed
dose.  In our study, we will target vitamin D3 blood levels typically
seen in young people with daily intense sun exposure".

Just

>The following information was posted on another PCa newsgroup with the
>request that it be shared...ron
[quoted text clipped - 55 lines]
>Sincerely,
>Charles "Snuffy" Myers, M.D.
ron - 12 Mar 2008 23:05 GMT
Sorry Just, I don't know anymore than what I posted.  There is e-mail
and phone contact info and I suspect whoever is on the other end can
get answers your questions...ron
Just - 13 Mar 2008 00:19 GMT
This is a site related to Charles "Snuffy" Myers and FCRE (mentioned
in your quote):
http://www.cancer-foundation.org/about.html

However, there is no reference whatsoever to the Phase II study. And
the site seems fairly outdated...

Just

>Sorry Just, I don't know anymore than what I posted.  There is e-mail
>and phone contact info and I suspect whoever is on the other end can
>get answers your questions...ron

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