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Herbal Therapy for Treatment of Recurrent Prostate Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Herbal Therapy for Treatment of Recurrent Prostate Cancer

A Phase II Trial of a Combination Herbal Therapy for Men With Biochemical Recurrence of Prostate Cancer After Initial Local Therapy

NCT00669656•University of Southern California

View on ClinicalTrials.gov

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

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

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Age greater than or equal to 18
•Histologically documented adenocarcinoma of the prostate
•Initial treatment with radical prostatectomy or external beam radiation
•* Neoadjuvant/Adjuvant Androgen Deprivation therapy allowable, provided it was for a maximum of 24 months, with the last dose of medication at least 12 months previously
•* Neoadjuvant or adjuvant chemotherapy allowable, provided it was for a maximum of 6 months, with the last dose of medication at least 12 months previously
•* Adjuvant radiation after radical prostatectomy is allowed, provided at least 6 months have elapsed between completion of radiation and enrollment in study
•PSA recurrence, with a rising PSA, as defined by:
•* Post Radiation Therapy:
•* Absolute PSA \>2.0 ng/mL
•* PSA nadir \<4 ng/mL after radiation
+24 more criteria

Exclusion Criteria

•Atypical prostate carcinoma histology (ex: small cell, adenoid cystic)
•Evidence of bony or soft tissue metastatic disease on CT/MRI or bone scan or PET/CT
•Other invasive malignancy within prior 3 years, except for fully treated basal cell or squamous cell carcinoma of the skin.
•Full-dose anticoagulation therapy (warfarin or low molecular weight heparin) or antiplatelet therapy (clopidogrel or ticlopidine), with the exception of low-dose aspirin therapy (81 mg).
•Significant cardiac disease, included but not limited to angina, myocardial infarction, cardiomyopathy, congestive heart failure, and coronary artery disease which has required bypass surgery, angioplasty or stent placement.
•Significant uncontrolled comorbid condition which, in the opinion of the treating physician would compromise the subject's ability to comply with protocol requirements, or would pose undue risk for experiencing adverse events.

Locations (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, United States

Key Dates

Start Date

July 6, 2008

Primary Completion Date

July 8, 2014

Completion Date

October 14, 2014

Last Updated

April 20, 2017

Enrollment

ACTUAL participants

Conditions

Prostate Cancer

Interventions

Prostate Health Cocktail

DRUG

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

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RECRUITINGPHASE2

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT06842498

Metastatic Castration-Resistant Prostate Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Herbal Therapy for Treatment of Recurrent Prostate Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of FG-3246 in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Testing the Safety and Effectiveness of Radiation-based Treatment (Lutetium Lu 177 Dotatate) for Metastatic Prostate Cancer That Has Neuroendocrine Cells

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

PSMA-PET: Deep Radiomic Biomarkers of Progression and Response Prediction in Prostate Cancer

Phase 2a Study of High-Dose Testosterone Followed by Radioligand Therapy in mCRPC