Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00060086
First received: May 6, 2003
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Prostate Cancer
Dietary Supplement: pomegranate juice
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2003
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00060086

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1738
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00060086     History of Changes
Other Study ID Numbers: CDR0000299439, P30CA016042, UCLA-0210049
Study First Received: May 6, 2003
Last Updated: August 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014