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