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
- 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
- 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
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intermediate endpoint biomarker modulation
George Wilding, MD
University of Wisconsin, Madison
United States: Federal Government
|Medical College of Wisconsin Cancer Center||Milwaukee, Wisconsin 53226|
|Veterans Affairs Medical Center - Madison||Madison, Wisconsin 53705|
|University of Wisconsin Comprehensive Cancer Center||Madison, Wisconsin 53792|
|Holden Comprehensive Cancer Center at University of Iowa||Iowa City, Iowa 52242-1002|
|James P. Wilmot Cancer Center at University of Rochester Medical Center||Rochester, New York 14642|
|Meriter Hospital||Madison, Wisconsin 53715|