Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

Sponsor
Jonsson Comprehensive Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT00060086
Collaborator
POM Wonderful LLC (Industry)
47
1
1
197.8
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: pomegranate juice
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate
Actual Study Start Date :
Nov 30, 2004
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
May 25, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months [Evaluated every 3 months for 18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jonsson Comprehensive Cancer Center at UCLA Los Angeles California United States 90095-1738

Sponsors and Collaborators

  • Jonsson Comprehensive Cancer Center
  • POM Wonderful LLC

Investigators

  • Principal Investigator: Allan Pantuck, MD, Jonsson Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00060086
Other Study ID Numbers:
  • 11-001265
  • UCLA-0210049
  • CDR0000299439
First Posted:
May 7, 2003
Last Update Posted:
Jun 4, 2021
Last Verified:
Jun 1, 2021
Keywords provided by Jonsson Comprehensive Cancer Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 4, 2021