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| Descriptive Information Fields | |||||||||
| Brief Title † | Pomegranate Extract in Treating Patients With Rising Prostate-Specific Antigen Levels After Surgery or Radiation Therapy for Localized Prostate Cancer | ||||||||
| 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 | ||||||||
| Brief Summary | 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 phase III trial is studying how well pomegranate extract works in treating patients with rising PSA levels after surgery or radiation therapy for localized prostate cancer. |
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| Detailed Description | 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. |
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| Study Phase | Phase III | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Treatment, Randomized, Double-Blind, Placebo Control | ||||||||
| Primary Outcome Measure † | Objective response [ Designated as safety issue: No ] | ||||||||
| Secondary Outcome Measure † | Response duration [ Designated as safety issue: No ] Effects of pomegranate extract on prostate-specific antigen (PSA) doubling and velocity times [ Designated as safety issue: No ] |
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| Condition † | Prostate Cancer | ||||||||
| Intervention † | Drug: placebo Drug: pomegranate juice |
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| MEDLINE PMIDs | |||||||||
| Links | Clinical trial summary from the National Cancer Institute's PDQ® database ![]() Featured trial article  ![]() |
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 180 | ||||||||
| Start Date † | November 2005 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Gender | Male | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† | |||||||||
| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00336934 | ||||||||
| Organization ID | CDR0000480402 | ||||||||
| Secondary IDs †† | ROLL-GUP-0205-1, UCLA-0507059-01 | ||||||||
| Study Sponsor † | Roll International Corporation | ||||||||
| Collaborators †† | National Cancer Institute (NCI) | ||||||||
| Investigators † |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | July 2008 | ||||||||
| First Received Date † | June 13, 2006 | ||||||||
| Last Updated Date | July 31, 2008 | ||||||||