Spots Global Cancer Trial Database for Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

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Trial Identification

Brief Title: Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Official Title: Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN

Study ID: NCT00022412

Conditions

Prostate Cancer

Interventions

doxercalciferol

conventional surgery

Study Description

Brief Summary: RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery. PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.

Detailed Description: OBJECTIVES: * Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer. * Assess the toxicity of this drug in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms. * Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy. * Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.