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: Phase II trial to study the effectiveness of pomegranate juice in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer	Drug: pomegranate juice  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: complementary and alternative therapy  Procedure: herbal medicine / botanical therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Must have undergone prior surgery or radiotherapy for the primary tumor
• No nodal involvement
• No evidence of metastatic disease
• 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

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 6 months

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• 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

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• No prior hormonal therapy
• No concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

Other

• More than 4 weeks since prior participation in another experimental study
• No concurrent participation in another experimental study
• No other concurrent systemic or local therapy for prostate cancer
• No initiation or discontinuation of any new nutritional or dietary supplements during study participation

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1738,  United States; Recruiting

Study chairs or principal investigators

Allan Pantuck, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000299439; UCLA-0210049; NCT00060086
Record last reviewed:  April 2003
Last Updated:  December 6, 2004
Record first received:  May 6, 2003
ClinicalTrials.gov Identifier:  NCT00060086
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08