Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Jonsson Comprehensive Cancer Center

ClinicalTrials.gov Identifier:

NCT00060086

First received: May 6, 2003

Last updated: September 30, 2016

Last verified: September 2016

History of Changes

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:

Genetics Home Reference related topics: prostate cancer

MedlinePlus related topics: Prostate Cancer

U.S. FDA Resources

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 ]


Estimated Enrollment:	40
Study Start Date:	March 2003
Estimated Primary Completion Date:	December 2017 (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 (Adult, Senior)
Sexes 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

National Cancer Institute (NCI)

Investigators


Study Chair:	Allan Pantuck, MD	Jonsson Comprehensive Cancer Center

More Information


Responsible Party:	Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00060086 History of Changes
Other Study ID Numbers:	CDR0000299439 P30CA016042 ( US NIH Grant/Contract Award Number ) UCLA-0210049
Study First Received:	May 6, 2003
Last Updated:	September 30, 2016

Keywords provided by Jonsson Comprehensive Cancer Center:


adenocarcinoma of the prostate recurrent prostate cancer

Additional relevant MeSH terms:


Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site	Neoplasms Genital Diseases, Male Prostatic Diseases

ClinicalTrials.gov processed this record on June 28, 2017

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