Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate
18 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months
Outcome Time Frame:
Evaluated every 3 months for 18 months
Safety Issue:
No
Principal Investigator
Allan Pantuck, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000299439
NCT ID:
NCT00060086
Start Date:
March 2003
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- recurrent prostate cancer
- Adenocarcinoma
- Prostatic Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
