Herbal Therapy for Treatment of Recurrent Prostate Cancer
This study is about Prostate Health Cocktail, a combination supplement that contains vitamin D3, vitamin E, selenium, green tea extract, saw palmetto, lycopene, and soy derivatives. This product is currently available on the market, as herb and vitamin supplements are not regulated by the FDA. Each ingredient has been studied in prostate cancer cells and/or in patients with prostate cancer. At the doses included in this supplement, no serious side effects have been reported.
The purpose of this study is to find out whether Prostate Health Cocktail can lower your PSA. Additionally, we will be looking to see whether taking this treatment causes any unexpected side effects, and whether certain blood tests can inform us about your disease status in addition to your PSA
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy|
- The primary endpoint of this trial will be PSA response [ Time Frame: PSA measurement every 4 weeks ] [ Designated as safety issue: No ]
- Toxicity and side effects [ Time Frame: Assessed every 4 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2008|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
|Experimental: Prostate Health Cocktail||
Drug: Prostate Health Cocktail
3 capsules daily PO up 12 months
Objectives of this study are:
- To assess the PSA response in prostate cancer patients who have a PSA-only disease recurrence after curative local therapy, during treatment with a combination herbal supplement.
- To qualitatively and quantitatively describe the toxicity profile of this herbal supplement.
- To assess changes in PSA doubling time for subjects treated with this supplement.
- To measure tissue GRP78, serum neuroendocrine markers, and circulating tumor cells, for correlation with treatment response and prostate cancer outcomes