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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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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 : November 30, 2004
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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.




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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060086


Locations
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United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1738
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Study Chair: Allan Pantuck, MD Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00060086    
Other Study ID Numbers: 11-001265
UCLA-0210049
CDR0000299439 ( Other Identifier: UCLA IRB )
First Posted: May 7, 2003    Key Record Dates
Last Update Posted: July 31, 2020
Last Verified: July 2020
Keywords provided by Jonsson Comprehensive Cancer Center:
adenocarcinoma of the prostate
recurrent prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases