Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer
RATIONALE: Pomegranate juice may contain substances that decrease or slow the rise of prostate-specific antigen (PSA) levels and may be effective in delaying or preventing recurrent prostate cancer.
PURPOSE: This phase II trial is studying how well pomegranate juice works in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate|
- Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months [ Time Frame: Evaluated every 3 months for 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2003|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Pomegranate Juice
Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Dietary Supplement: pomegranate juice
Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
- Determine whether pomegranate juice can decrease or slow rising prostate-specific antigen (PSA) levels in patients who have undergone radical prostatectomy or radiotherapy for adenocarcinoma of the prostate.
OUTLINE: Patients receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 29-40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060086
|United States, California|
|Jonsson Comprehensive Cancer Center at UCLA|
|Los Angeles, California, United States, 90095-1738|
|Study Chair:||Allan Pantuck, MD||Jonsson Comprehensive Cancer Center|