Services / Prostate Cancer - Pomegranate
Trial Information
Prostate Cancer: Clinical Trial of pomegranate liquid extract for men with rising PSA after primary treatment.
- Principal Investigator: Allan Pantuck, M.D
- Co-Investigators: Arie Belldegrun, M.D., Jean deKernion, M. Robert Reiter, M.D., Mark Litwin, M.D., Matthew Rettig, M.D.
This trial is currently accepting new patient applications
Objective:
A Study of the Effects of Pomegranate Juice or Extract On Rising Prostate-Specific Antigen (PSA) Levels in Men Following Primary Therapy for Prostate Cancer
The purpose of this study is to compare the effects of daily consumption of pomegranate liquid extract and placebo in lowering PSA or stopping PSA from increasing.
Pomegranate juice contains ingredients that are known to prevent damage to cells. Pomegranate juice studies have shown that it may be more powerful at cancer prevention than green tea. Many of the ingredients found in pomegranate juice may be able to slow the growth of human prostate cancer.
Trial Design
Randomized, Placebo Controlled Phase 3 Study
If you are eligible for the study, you will be entered into one of the two study groups. Which study beverage you will drink will depend on which of the two groups (Pomegranate liquid extract or Placebo Juice) you are assigned to. This study is a randomized study, meaning that this assignment will be determined by chance, in a process similar to flipping a coin. You have a 2 out of 3 chance that you will receive active juice. This is a double-blind study, meaning that neither you nor the study doctor will know which group you are assigned to unless that information is important (such as in an emergency). If your prostate cancer progresses while you are in the study, you will be withdrawn from the study. At that time you and your doctor will be unblinded. If it turns out that you are on the placebo, you will be eligible to enter into another study where you will receive the pomegranate extract.
Groups
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Intervention
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1: Experimental
Pomegranate liquid extract
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Drug: Pomegranate extract
8 ounces daily for 52 weeks
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2:Placebo Control
juice
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Drug: Placebo
8 ounces daily for 52 weeks
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Patient Eligibility
Inclusion Criteria:
- Histologically confirmed adenocarcinoma of the prostate
- No evidence of metastatic disease
- Must have completed prior surgery, cryotherapy, or radiotherapy for the primary tumor
- Documented rising prostate-specific antigen (PSA)
> 1.0 after radiation or cryotherapy
> .4 after treatment with multiple modalities (ie surgery and radiation.
Exclusion Criteria:
- PSA > 7.0 ng/mL
- Patients who underwent radical prostatectomy and never achieved undetectable serum PSA after surgery.
- Hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy
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- Patients who received prior neoadjuvant ADT must have serum testosterone ≥ 150 ng/dL
- Use of finasteride or dutasteride at any time point after primary therapy and during study therapy
The above information is not intended to contain all considerations relevant to a patient’s potential participation in a clinical trial.
For more information
For additional information on inclusion and exclusion criteria and whether or not you may be a candidate to participate in a trial, call recruitment coordinator Diana Sarkisyan at (310) 206-7793 (dsarkisyan@mednet.ucla.edu) or Nazy Zomorodian, Director for the Clinical Trials Office at (310) 794-7704.
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