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

NCT ID: NCT00336934

Last Updated: 2011-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 183 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm I

Patients receive oral pomegranate extract daily.

Group Type: EXPERIMENTAL

pomegranate juice

Intervention Type: DIETARY_SUPPLEMENT

Given orally daily.

Arm II

Patients receive oral placebo daily.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

Given orally daily.

Interventions

pomegranate juice

Given orally daily.

Intervention Type: DIETARY_SUPPLEMENT

placebo

Given orally daily.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Gleason score ≤ 7
• No histologically positive lymph nodes
• No evidence of metastatic disease by physical examination, CT scan, or bone scan

PATIENT CHARACTERISTICS:

• Life expectancy ≥ 6 months
• ECOG performance status 0 or 1
• No significant concomitant medical or psychiatric conditions that would limit study compliance
• No known allergies to pomegranate extract
• No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months

• Diabetic patients entering study who have not had hemoglobin A_1c level measured in the past 3 months must have levels measured at study initiation
• No clinically abnormal laboratory values > 2 times the upper limit of normal

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 4 weeks since prior and no concurrent experimental drugs, high-dose steroids, or other cancer treatment
• No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy

• Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL
• No prior or concurrent hormonal therapy for rising PSA after primary therapy for prostate cancer
• No finasteride or dutasteride at any time point after primary therapy and during study therapy
• No other concurrent commercial pomegranate products
• No other concurrent systemic or local therapy for prostate cancer
• Concurrent dietary/herbal supplements (e.g., saw palmetto or selenium) allowed provided dose has been stable for ≥ 2 months prior to study entry and there are no plans to change or stop the supplements during study therapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Roll International Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Radiant Research - Chicago

Principal Investigators

Allan Pantuck, MD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Arie Belldegrun, MD, FACS

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Other Identifiers

P30CA016042

Identifier Type: NIH

Identifier Source: secondary_id

View Link

ROLL-GUP-0205-1

Identifier Type: -

Identifier Source: secondary_id

UCLA-0507059-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000480402

Identifier Type: -

Identifier Source: org_study_id

NCT00413530

Identifier Type: -

Identifier Source: nct_alias