Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00060086
Recruitment Status : Active, not recruiting
First Posted : May 7, 2003
Last Update Posted : July 31, 2020
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE May 6, 2003
First Posted Date  ICMJE May 7, 2003
Last Update Posted Date July 31, 2020
Actual Study Start Date  ICMJE November 30, 2004
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE 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  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 3, 2011)
40
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00060086
Other Study ID Numbers  ICMJE 11-001265
UCLA-0210049
CDR0000299439 ( Other Identifier: UCLA IRB )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonsson Comprehensive Cancer Center
Study Sponsor  ICMJE Jonsson Comprehensive Cancer Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
PRS Account Jonsson Comprehensive Cancer Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP