Herbal Therapy for Treatment of Recurrent Prostate Cancer

NCT00669656 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: 4P-07-3
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this trial will be PSA response

  PSA measurement every 4 weeks

Secondary Outcomes (1)

• Toxicity and side effects

  Assessed every 4 weeks

Study Arms (1)

Prostate Health Cocktail

EXPERIMENTAL

Drug: Prostate Health Cocktail

Interventions

Prostate Health Cocktail DRUG

3 capsules daily PO up 12 months

Also known as: Cholecalciferol, Vitamin D3, d-alpha tocopherol, vitamin E, L-selenomethionine, selenium, green tea extract, EGC, Epigallocatechin, saw palmetto, lycopene, Isoflavanoids, Daidzein, Genisetein

Prostate Health Cocktail

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Absolute rise of at least 0.5 ng/mL total
• At least 2 increases in PSA, separated by at least 2 weeks; these can be separated by a PSA value which declines provided the second rising value is higher than the first rising value.
• Post Prostatectomy:
• Absolute PSA \>1.0 ng/mL
• Absolute rise of at least 1 ng/mL total from nadir

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol; alpha-Tocopherol; Vitamin E; Selenium; Tea; gallocatechol; saw palmetto extract; Lycopene; daidzein

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Tocopherols; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chalcogens; Elements; Inorganic Chemicals; Minerals; Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Tanya Dorff, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2008
• First Posted: April 30, 2008
• Study Start: July 6, 2008
• Primary Completion: July 8, 2014
• Study Completion: October 14, 2014
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (1)