Spots Global Cancer Trial Database for Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
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Trial Identification
Brief Title: Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
Official Title: Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy
Study ID: NCT01325311
Study Description
Brief Summary: This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.
Detailed Description: PRIMARY OBJECTIVES: I. To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo. SECONDARY OBJECTIVES: I. To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy. ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, Maryland, United States
Lahey Hospital and Medical Center, Burlington, Massachusetts, United States
Minneapolis Veterans Medical Center, Minneapolis, Minnesota, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
University of Rochester, Rochester, New York, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Carolina Urologic Research Center, Myrtle Beach, South Carolina, United States
Urology San Antonio Research PA, San Antonio, Texas, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Contact Details
Name: David Jarrard
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR
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