NCT01220817

Safety and Efficacy of POMx Capsules in Men With Recurrent Prostate Cancer: An 18-Month Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: POM Wonderful LLC · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Prostate Cancer

Interventions

Type	Name	Description
DRUG	3 POMx capsules	3 POMx capsules daily
DRUG	1 POMx capsule	1 POMx capsule daily

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2010-10-14
• Last updated: 2012-04-06

Locations

1 site across 1 country: United States