Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00060086
• Recruitment Status: Active, not recruiting
• First Posted: May 7, 2003
• Last Update Posted: July 31, 2020
• Sponsor: Jonsson Comprehensive Cancer Center
• Information provided by (Responsible Party): Jonsson Comprehensive Cancer Center

Tracking Information

• First Submitted Date: May 6, 2003
• First Posted Date: May 7, 2003
• Last Update Posted Date: July 31, 2020
• Actual Study Start Date: November 30, 2004
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: August 3, 2011): 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 ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Prostate Cancer

Intervention

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.

Study Arms

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.

Intervention: Dietary Supplement: pomegranate juice

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 3, 2011): 40
• Original Enrollment: Not Provided
• Estimated Study Completion Date: December 2022
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00060086
• Other Study ID Numbers: 11-001265; UCLA-0210049; CDR0000299439 ( Other Identifier: UCLA IRB )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Jonsson Comprehensive Cancer Center
• Study Sponsor: Jonsson Comprehensive Cancer Center
• Collaborators: Not Provided

Investigators

• Study Chair: Allan Pantuck, MD; Jonsson Comprehensive Cancer Center

• PRS Account: Jonsson Comprehensive Cancer Center
• Verification Date: July 2020