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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: pomegranate juice
* Other: placebo


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Patients receive oral pomegranate extract daily. | Dietary Supplement: pomegranate juice<br>* Given orally daily.<br>|
| Placebo Comparator: Arm II<br>Patients receive oral placebo daily. | Other: placebo<br>* Given orally daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response duration |  | 12 months | 
| Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer