Spots Global Cancer Trial Database for Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study
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Trial Identification
Brief Title: Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study
Official Title: Safety and Efficacy of POMx in Men With Prostate Cancer: An 18-Month, Randomized, Double-Blind, Dose-Finding Study of the Effects of Two (2) Doses of Pomegranate Juice Extract Capsules (1 or 3 Capsules/Day) on Rising Prostate Specific Antigen Levels in Men Following Initial Therapy for Prostate Cancer
Study ID: NCT01220817
Conditions
Study Description
Brief Summary: When given to men with recurrent prostate cancer, the investigators hypothesize that POMx is effective in slowing the rise of PSA as measured by PSA doubling time in men following initial therapy for prostate cancer. Further, the investigators believe that POMx will be shown to be safe and well tolerated.
Detailed Description: The study will be an 18-month, prospective, multi-center, double-blind, dose finding study with subjects who have undergone definitive treatment (surgery, cryotherapy, radiation therapy or brachytherapy) for primary prostate tumor and have had documented rising PSA on a minimum of 3 time points each at least 1 month apart, higher than the reference value noted within 1 year of study entry.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Johns Hopkins University, Baltimore, Maryland, United States
Contact Details
Name: Michael Carducci, MD
Affiliation: Sidney Kimmel Cancer Center, Johns Hopkins University
Role: PRINCIPAL_INVESTIGATOR
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