March 11, 2008

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

Dear Kathy:

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,