Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

Launched by JONSSON COMPREHENSIVE CANCER CENTER · May 6, 2003

Keywords

ClinConnect Summary

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.

Gender

MALE

Eligibility criteria

• 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