Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

June 1, 2021 updated by: Jonsson Comprehensive Cancer Center

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

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: This phase II trial is studying how well pomegranate juice works in decreasing or slowing the rise of PSA levels in patients who have undergone radiation therapy or surgery for prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095-1738
        • Jonsson Comprehensive Cancer Center at UCLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pomegranate Juice
Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Dietary supplement: pomegranate juice
Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months
Time Frame: Evaluated every 3 months for 18 months
Evaluated every 3 months for 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonsson Comprehensive Cancer Center

Collaborators

POM Wonderful LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2004

Primary Completion (Actual)

May 25, 2021

Study Completion (Actual)

May 25, 2021

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Actual)

June 4, 2021

Last Update Submitted That Met QC Criteria

June 1, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-001265
  • UCLA-0210049
  • CDR0000299439 (Other Identifier: UCLA IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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