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Extension to Study of Effects of Pomegranate Extract on Rising PSA Levels After Primary Therapy for Prostate Cancer

NCT00732043 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-03-16

No results posted yet for this study

Summary

High concentrations of anti-oxidants in pomegranate seeds present a potential strategy to delay clinical prostate cancer progression and prolong the interval from primary treatment failure to hormonal ablation. This is a 48 month extension to the double-blind GUP-0205-1 study, to compare the effects of daily consumption of pomegranate liquid extract versus placebo on the absolute prostate-specific antigen (PSA) doubling time at the end of 12, 24, 36 and 48 months in male subjects who rolled-over from the GUP-0205-1 study.

Conditions

Interventions

DIETARY_SUPPLEMENT

pomegranate extract

8 oz per day, 48 months

DIETARY_SUPPLEMENT

pomegranate juice

8 oz per day, 48 months

DIETARY_SUPPLEMENT

placebo

8 oz per day, 48 months

Sponsors & Collaborators

  • Roll International Corporation

    lead INDUSTRY

Principal Investigators

  • Allan J Pantuck, MD · University of California, Los Angeles

  • Arie S Belldegrun, MD · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2014-01-31
Completion
2015-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00732043 on ClinicalTrials.gov