Herbal Therapy for Treatment of Recurrent Prostate Cancer
|ClinicalTrials.gov Identifier: NCT00669656|
Recruitment Status : Completed
First Posted : April 30, 2008
Last Update Posted : April 20, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Prostate Health Cocktail||Phase 2|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy|
|Actual Study Start Date :||July 6, 2008|
|Actual Primary Completion Date :||July 8, 2014|
|Actual Study Completion Date :||October 14, 2014|
|Experimental: Prostate Health Cocktail||
Drug: Prostate Health Cocktail
3 capsules daily PO up 12 months
- The primary endpoint of this trial will be PSA response [ Time Frame: PSA measurement every 4 weeks ]
- Toxicity and side effects [ Time Frame: Assessed every 4 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00669656
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Tanya Dorff, MD||University of Southern California|