|No phase specified||Treatment||Completed||18 and over||NCI, Other||CDR0000480402|
P30CA016042, ROLL-GUP-0205-1, UCLA-0507059-01, NCT00336934
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.
Further Study Information
- 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.
- 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.
- 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
- 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
Trial Lead Organizations/Sponsors
Roll International CorporationNational Cancer Institute
|Allan Pantuck||Principal Investigator|
|Arie Belldegrun||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00336934
Information obtained from ClinicalTrials.gov on November 20, 2012
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