Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-07 @ 2:09 PM
Study NCT ID:
NCT00669656
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2008-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Herbal Therapy for Treatment of Recurrent Prostate Cancer
Sponsor:
University of Southern California
Organization:
Study Overview
Official Title:
A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: