Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
Roll International Corporation
- National Cancer Institute
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00336934
ClinicalTrials.gov processed this data on October 17, 2013
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.