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Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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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 UCLALos Angeles, California  90095-1781