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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
Procedure: Prostatectomy for prostate cancer
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States
Meriter Hospital
Madison, Wisconsin, United States
Intermediate endpoint biomarker modulation
Time frame: 18 months
Toxicity
Time frame: 30 months
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University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States