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Spots Global Cancer Trial Database for Genistein in Treating Patients With Prostate Cancer

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Trial Identification

Brief Title: Genistein in Treating Patients With Prostate Cancer

Official Title: Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells

Study ID: NCT01126879

Study Description

Brief Summary: RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. PURPOSE: This randomized phase II trial is studying how well genistein works in treating patients with prostate cancer.

Detailed Description: PRIMARY OBJECTIVES: I. Determine whether genistein treatment will decrease the number of circulating prostate cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA extracted from peripheral blood mononuclear cells (PBMNCs). SECONDARY OBJECTIVES: I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of subjects prior to and post radical prostatectomy. II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the nano-PSA assay. III. Measure the effect of genistein on gene and protein expression in prostate tissue by qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month prior to radical prostatectomy. ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month prior to radical prostatectomy. All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months following the start of therapy. After completion of study treatment, patients are followed at 1, 6, and 12 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Northwestern University, Chicago, Illinois, United States

Contact Details

Name: William Catalona

Affiliation: Northwestern University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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