Expired Study
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Los Angeles, California 90033


Purpose:

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 summary:

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


Criteria:

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 - 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 - 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 value - PSA Doubling Time (PSA DT) more than 3 months and less than 36 months - PSA DT to be calculated using the web-based calculator at http://kevin.phys.unm.edu/psa/ with the following constraints: - At least 3 values, but no more than 6 - All values must be >0.2 - Values must be separated by at least 2 months - No radiographically evident bony or soft tissue metastases - Documented discussion between subject and physician about the option to pursue hormone therapy and/or salvage local therapy rather than enroll in this study - Patients who received treatment with androgen deprivation for biochemical recurrence are eligible provided: - They did not document castration resistance (defined as 2 rising PSA values while testosteron < 50 - They have been off androgen deprivation for at least 3 months and have recovered their testosterone (>150) - They have decided,in conjunction with their treating physician that they do not want to resume androgen deprivation - ECOG Performance Status 0-2 - Life expectancy > 12 months - Adequate hepatic function (AST, ALT, bilirubin <1.5 x ULN) - Adequate renal function (eGFR by Cockcroft-Gault or comparable calculation >50 ml/min) - Willing to discontinue all nutritional supplements and 5-alpha reductase inhibitors (finasteride, dutasteride) for the duration of study treatment, unless the medication is being used to control symptoms of BPH and the patient has been taking the medication for more than 6 weeks - Willing to discontinue all weight control medications for the duration of study treatment - Signed informed consent 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.


Study is Available At:


Original ID:

4P-07-3


NCT ID:

NCT00669656


Secondary ID:


Study Acronym:


Brief Title:

Herbal Therapy for Treatment of Recurrent Prostate Cancer


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Southern California


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

43


Enrollment Type:

Actual


Overall Contact Information

Official Name:Tanya Dorff, MD
Principal Investigator
University of Southern California

Study Dates

Start Date:July 6, 2008
Completion Date:October 14, 2014
Completion Type:Actual
Primary Completion Date:July 8, 2014
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:April 18, 2017
First Received Date:April 28, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Toxicity and side effects
Time Frame:Assessed every 4 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The primary endpoint of this trial will be PSA response
Time Frame:PSA measurement every 4 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Prostate Health Cocktail
Description:3 capsules daily PO up 12 months
Arm Name:Prostate Health Cocktail
Other Name:Cholecalciferol

Study Arms

Study Arm Type:Experimental
Arm Name:Prostate Health Cocktail

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Southern California

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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