Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: pomegranate juice; Other: placebo

• Registration Number: NCT00336934
• Lead Sponsor: Roll International Corporation

Brief Summary

RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer.

PURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* Evaluate the effects of pomegranate extract in patients with and rising prostate-specific antigen (PSA) levels after surgery or radiotherapy for localized prostate cancer.

* Determine the effect of a daily oral dose of pomegranate extract on the absolute value of PSA and on the change in PSA doubling time in these patients.

Secondary

* Assess toxicities associated with daily oral dosing of pomegranate extract in these patients.

* Determine the effect of pomegranate extract on positive PSA doubling-time outcome, defined as greater than 150% baseline or a negative post-treatment PSA doubling time (i.e., declining PSA).

OUTLINE: This is a multicenter, double-blind, placebo-controlled, randomized study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral pomegranate extract daily.

* Arm II: Patients receive oral placebo daily. Treatment in both arms continues for up to 1 year in the absence of disease progression.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.

Study Timeline

• Study Start: 2005-11
• Study First Submitted: 2006-06-13
• Study First Submitted QC: 2006-06-13
• Study First Posted: 2006-06-15
• Primary Completion: 2010-07
• Study Completion: 2010-12
• Disposition First Submitted: 2011-03-15
• Disposition First Submitted QC: 2011-05-16
• Disposition First Posted: 2011-05-19
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-08
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 183

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I	pomegranate juice	Patients receive oral pomegranate extract daily.
Arm II	placebo	Patients receive oral placebo daily.

Primary Outcome Measures

Name	Time	Method
Objective response	12 months

Secondary Outcome Measures

Name	Time	Method
Response duration	12 months
Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times	12 months