Prostate Cancer Clinical Trial
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
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.
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