Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
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.
|Prostate Cancer||Dietary Supplement: doxercalciferol Procedure: conventional surgery||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Intermediate endpoint biomarker modulation [ Time Frame: 18 months ]
- Toxicity [ Time Frame: 30 months ]
|Study Start Date:||August 2001|
|Study Completion Date:||August 2008|
|Primary Completion Date:||February 2006 (Final data collection date for primary outcome measure)|
Placebo Comparator: Observation, then prostatectomy
Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
Procedure: conventional surgery
Procedure: Prostatectomy for prostate cancer
Other Name: Prostatectomy - no dietary supplement
Active Comparator: Doxercalciferol once daily for 28 days
Dietary supplement once daily to treat prostate cancer for 28 days
Dietary Supplement: doxercalciferol
Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
Other Name: Localized adenocarcinoma of the prostate
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022412
|United States, Iowa|
|Holden Comprehensive Cancer Center at University of Iowa|
|Iowa City, Iowa, United States, 52242-1002|
|United States, New York|
|James P. Wilmot Cancer Center at University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|United States, Wisconsin|
|Veterans Affairs Medical Center - Madison|
|Madison, Wisconsin, United States, 53705|
|Madison, Wisconsin, United States, 53715|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792-6164|
|Medical College of Wisconsin Cancer Center|
|Milwaukee, Wisconsin, United States, 53226-3596|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|