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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.
Full description
OBJECTIVES:
Primary
Secondary
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.
PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study.
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Inclusion and exclusion 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
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
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
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
Primary purpose
Allocation
Interventional model
Masking
183 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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