This trial is active, not recruiting.

Condition prostate cancer
Treatment muscadine plus grape skin extract
Phase phase 1/phase 2
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator Howard University
Start date July 2011
End date November 2015
Trial size 139 participants
Trial identifier NCT01317199, J1161


This research is being done to test an investigational product called Muscadine Plus in the treatment of men who have received initial therapy (surgery and or radiation, cryotherapy or brachytherapy) for prostate cancer and are experiencing a rise in their prostate-specific antigens (PSA) level.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
muscadine plus grape skin extract
Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle Phase II: to be determined after maximum tolerated dose in Phase I is established

Primary Outcomes

(Phase I) Maximum Tolerated Dose
time frame: Approximately 7 months to reach MTD
(Phase II) Define the effects of placebo and two different daily doses of Muscadine Plus on PSA doubling time
time frame: Up to 3 years

Secondary Outcomes

(Phase I)Number of Participants with Adverse Events as a Measure of Safety and Tolerability
time frame: Up to 3 years
(Phase II) To estimate other measures of PSA kinetics
time frame: Up to 3 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed adenocarcinoma of the prostate. - Undergone definitive treatment (surgery, surgery with radiation therapy, cryotherapy, radiation therapy or brachytherapy) for the primary prostate tumor. - Rising PSA on a minimum of 3 time points (including screening psa) within the 12 months prior to study initiation. - > 18 years of age. - Life expectancy of greater than 6 months. - ECOG performance status 0, 1 or 2. - Testosterone level of ≥1.5 ng/mL at screening. - Adequate kidney, liver and bone marrow function - Agrees to abstain from other commercially available MP products while participating in this study. - Subject's use of other dietary/herbal supplements (e.g. saw palmetto, selenium, etc) has been stable for at least 2 months prior to screening and the subject agrees not to stop or change the dose(s) while participating in the study. - Signed a written informed consent document and agrees to comply with requirements of the study. Exclusion Criteria: - Known radiographic evidence of metastatic disease, except for presence of positive lymph nodes from the surgical pathology. Pelvic/intraperitoneal lymph nodes less than 2.0 cm maybe considered nonspecific and the patient would be eligible - Receipt of any therapies that modulate testosterone levels (e.g., androgen ablative/anti-androgen therapy, 5 alpha reductase inhibitors) for a minimum of 6 months prior to study - Prior or concomitant treatment with experimental drugs, high dose steroids, or any other cancer treatment within 4 weeks prior to the first dose of the study product - Consumption of Muscadine Plus over the past 2 months - Known allergy to muscadine grapes or ellagic acid - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Negative PSA doubling time (1 time point may be excluded per 3e inclusion criteria)

Additional Information

Official title Phase I/II Study of Safety and Efficacy of Muscadine Plus (MPX) in Men With Prostate Cancer: a Randomized,Double-blind,Placebo Controlled Study of the Effects of Two Doses of MPX Capsules on Rising Prostate-specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
Principal investigator Michael A Carducci, MD
Description In phase I the investigators are evaluating the safety of the product and checking blood levels of the active components. In phase II the investigators are evaluating the effect of MPX on PSA doubling time
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.