Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

OBJECTIVES:

• 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.

Inclusion criteria

• Histologically confirmed adenocarcinoma of the prostate
• Must have undergone prior surgery or radiotherapy for the primary tumor
• Documented rising prostate-specific antigen (PSA) level, defined by the following criteria:
• Absolute level of PSA at least 0.2 ng/mL but less than 5.0 ng/mL
• Rising PSA level must be confirmed at least 1 week later
• Adequate PSA time points to calculate a PSA doubling time
• Gleason score no greater than 7
• Age 18 and over
• Performance status ECOG 0-1
• Life expectancy at least 6 months
• No other malignancy within the past 5 years except nonmelanoma skin cancer
• No other serious concurrent systemic medical disorders that would preclude study compliance
• No known allergy to pomegranate juice
• More than 4 weeks since prior participation in another experimental study

Exclusion criteria

• nodal involvement
• evidence of metastatic disease
• prior hormonal therapy
• concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer
• concurrent participation in another experimental study
• other concurrent systemic or local therapy for prostate cancer
• initiation or discontinuation of any new nutritional or dietary supplements during study participation