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| Sponsor: | Roll International Corporation |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Roll International Corporation |
| ClinicalTrials.gov Identifier: | NCT00336934 |
Purpose
RATIONALE: Pomegranate extract may keep prostate cancer from growing in patients with rising prostate-specific antigen (PSA) levels after surgery or radiation therapy for localized prostate cancer.
PURPOSE: This randomized trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer.
| Condition | Intervention |
|---|---|
|
Prostate Cancer |
Dietary Supplement: pomegranate juice Other: placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of The Effects of Pomegranate Extract On Rising Prostate-Specific Antigen Levels In Men Following Primary Therapy |
| Enrollment: | 183 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral pomegranate extract daily.
|
Dietary Supplement: pomegranate juice
Given orally daily.
|
|
Placebo Comparator: Arm II
Patients receive oral placebo daily.
|
Other: placebo
Given orally daily.
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, double-blind, placebo-controlled, randomized study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 180 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 |
DISEASE CHARACTERISTICS:
Documented rising prostate-specific antigen (PSA)
PSA doubling time > 3 months or ≤ 24 months
Patients must have ≥ 3 rising PSA time points above the minimum nadir achieved over ≥ 6 months
PATIENT CHARACTERISTICS:
No known diabetes with hemoglobin A_1c level > 7.0% in the past 3 months
PRIOR CONCURRENT THERAPY:
No hormonal therapy, with the exception of neoadjuvant androgen-deprivation therapy (ADT), prior to or concurrent with primary therapy
Contacts and Locations| Principal Investigator: | Allan Pantuck, MD | Jonsson Comprehensive Cancer Center |
| Principal Investigator: | Arie Belldegrun, MD, FACS | Jonsson Comprehensive Cancer Center |
More Information
| Responsible Party: | MaryBethAudickas, Radiant Research - Chicago |
| ClinicalTrials.gov Identifier: | NCT00336934 History of Changes |
| Other Study ID Numbers: | CDR0000480402, P30CA016042, ROLL-GUP-0205-1, UCLA-0507059-01 |
| Study First Received: | June 13, 2006 |
| Last Updated: | August 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer |
stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |