Prostate Cancer
Conditions
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer, stage I prostate cancer, stage II prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Interventions
Given orally daily.
Given orally daily.
Sponsors
Study design
Eligibility
Inclusion 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Response duration | 12 months |
| Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times | 12 months |