RATIONALE: Pomegranate juice 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 clinical trial is studying how well pomegranate juice works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.

Condition	Intervention
Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Stage IV Prostate Cancer	Drug: pomegranate juice  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: dietary intervention  Procedure: nutritional supplementation

Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:

Primary

• Evaluate the effects of pomegranate juice 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 juice 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 juice in these patients.
• Determine the effect of pomegranate juice 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 juice 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 250 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor
• Documented rising prostate-specific antigen (PSA)
• Absolute level of PSA > 0.2 ng/mL after surgery
• Absolute level of PSA > 1.0 ng/mL after radiation or cryotherapy
• Absolute level of PSA ≥ 0.4 ng/mL after multiple treatment modalities (e.g., surgery with radiotherapy or radiotherapy with cryotherapy)
• PSA must be ≥ 100% above best nadir achieved
• PSA doubling time > 3 months or ≤ 24 months
• Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months
• The interval between PSA time points must be > 2 weeks
• PSA ≤ 7.0 ng/mL
• Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery are not eligible
• 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 juice
• No known diabetes with hemoglobin A
• 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

Please refer to this study by ClinicalTrials.gov identifier  NCT00336934

California
      Jonsson Comprehensive Cancer Center at UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting

Study chairs or principal investigators

Allan Pantuck, MD,  Principal Investigator,  Jonsson Comprehensive Cancer Center   
Arie Belldegrun, MD, FACS,  Principal Investigator,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000480402; UCLA-0507059-01; ROLL-GUP-0205-1
Last Updated:  September 29, 2006
Record first received:  June 13, 2006
ClinicalTrials.gov Identifier:  NCT00336934

 

Learning about Prostate Cancer  (National Human Genome Research Institute)

Prostate Cancer: Glossary  (Cleveland Clinic Foundation)

Non-Risk Factors  (Prostate Cancer Foundation)

Prostate Cancer Screening: A Decision Guide  (National Center for Chronic Disease Prevention and Health Promotion)

Detailed Guide: Prostate Cancer  (American Cancer Society)

Prostate Cancer and Stress  (Cleveland Clinic Foundation)

What You Need to Know about Prostate Cancer  (National Cancer Institute)

Prostate Cancer (PDQ): Screening  (National Cancer Institute)

Prostate Cancer: What You Need to Know  (American Academy of Family Physicians)

Watchful Waiting  (Prostate Cancer Foundation)

Prostate Cancer (PDQ): Prevention  (National Cancer Institute)

Prostate Cancer Screening: A Decision Guide for African Americans  (Centers for Disease Control and Prevention)

Early Prostate Cancer: Questions and Answers  (National Cancer Institute)

Experimental Therapies  (Prostate Cancer Foundation)

Coping with Prostate Cancer  (Cleveland Clinic Foundation)

Prostate Cancer Specialists  (Cleveland Clinic Foundation)

Prostate Cancer  (National Cancer Institute)

Progress Report Newsletter  (Prostate Cancer Foundation)