Status:
COMPLETED
Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer
Lead Sponsor:
Roll International Corporation
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
NA
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. P...
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. * De...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT00336934
Start Date
November 1 2005
End Date
December 1 2010
Last Update
August 15 2011
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