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Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pomegranate juice
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, recurrent prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pomegranate Juice

Arm Description

Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
June 1, 2021
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
POM Wonderful LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00060086
Brief Title
Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer
Official Title
Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2004 (Actual)
Primary Completion Date
May 25, 2021 (Actual)
Study Completion Date
May 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
POM Wonderful LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, recurrent prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pomegranate Juice
Arm Type
Experimental
Arm Description
Subjects are given oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Intervention Type
Dietary Supplement
Intervention Name(s)
pomegranate juice
Intervention Description
Subjects receive oral pomegranate juice once daily. Treatment continues for 18 months in the absence of disease progression or unacceptable toxicity.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan Pantuck, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1738
Country
United States

12. IPD Sharing Statement

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Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

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