Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Prostate Cancer	Dietary Supplement: pomegranate juice	Not Applicable

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
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 :	March 2003
Estimated Primary Completion Date :	December 2020
Estimated Study Completion Date :	December 2021

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00060086 History of Changes
Other Study ID Numbers:	CDR0000299439; P30CA016042 ( U.S. NIH Grant/Contract ); UCLA-0210049; 11-001265 ( Other Identifier: UCLA IRB )
First Posted:	May 7, 2003
Last Update Posted:	October 13, 2017
Last Verified:	October 2017

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