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Pomegranate Juice in Treating Patients With Recurrent Prostate Cancer
This study is ongoing, but not recruiting participants.
First Received: May 6, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00060086
  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 II

MedlinePlus related topics: Cancer Prostate Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study Evaluating Pomegranate Juice In Patients With Recurrent Adenocarcinoma Of The Prostate

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Clinical efficacy, in terms of overall response rate, measured by serum prostate-specific antigen (PSA) levels every 3 months [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessed by frequency of adverse events every 3 months after treatment [ Designated as safety issue: Yes ]
  • Response duration measured by Kaplan-Meier curves at 3 months after treatment [ Designated as safety issue: No ]
  • Time to treatment failure measured by Kaplan-Meier curves at 3 months after treatment [ Designated as safety issue: No ]

Study Start Date: March 2003
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
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • Must have undergone prior surgery or radiotherapy for the primary tumor
  • No nodal involvement
  • No evidence of metastatic disease

  • 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

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • At least 6 months

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • No prior hormonal therapy
  • No concurrent hormonal therapy for rising PSA levels after initial therapy for prostate cancer

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

Other

  • More than 4 weeks since prior participation in another experimental study
  • No concurrent participation in another experimental study
  • No other concurrent systemic or local therapy for prostate cancer
  • No initiation or discontinuation of any new nutritional or dietary supplements during study participation
  Contacts and Locations
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

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000299439, UCLA-0210049
Study First Received: May 6, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00060086     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
recurrent prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
 Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male
 Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on May 06, 2009



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