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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.
A subject dear to my heart. I found very positive research results re. VitD3 Cholecalciferol supplements.
In the UK here, we get too lttle sunshine to supply a sufficient amount of D3 and yet the highest recommended supplement is only 800iu daily. Useless!!
Halfway through my hormone therapy I had to "demand" a Vit D 25-Hydroxy test. My onco couldn't see the need for such a test. The result showed that I was right to ask.
I had only 20% of the optimal amount.
I found an excellent FDA approved supplier of VitD Cholecalciferol capsules in the US who produce 5000iu doses.
I have been taking 5 one week, 6 the next, for many many months now, making my daily average supplement 4000iu and am looking forward to very good results from the next test (in December this year).
FYI:
At the advice of my Dentist and a family friend who is a Professor Emeritus of Pharmachology, I now take the following supplements that contain: AM, 650 IU Vit D3 and 800 mg Oyster shell calciium. PM, 1000 IU Vit D3 and 1000 mg Coral Calcium. My Urologists comment was, "It's a very good idea".
I know that I could almost double the amount without any toxicity problems.
This dose seems to have improved morning muscle and joint pain that I attribute to ADT. I have also upped my exercising from an average of 1 hour/day walking adding 30 min. of 4 day/week stationary bike "touring".
I understand that there may also be circulatory and digestive benefits as well.
I've been on Megace (20mg x 2/day) for about five weeks but for the last few days the hot flashes are coming back with a vengence. I don't know if the increase of exercise is responsible but the steroid makes me want to eat everything in sight so I'm seriously thinking about contacting the Doc for a withdrawal strategy. (Alaska, USA)
