A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
- Determine the effects of calcitriol in patients with high-grade prostatic
- Determine the toxicity of this drug in these patients.
- Determine the effect of this drug on prostate specific antigen in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every
8 weeks for 2 courses in the absence of unacceptable toxicity.
After completion of course 2 (week 16), patients undergo biopsy. Patients continue to
receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated.
Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy
receive 2 additional courses of calcitriol. Patients with no HGPIN or prostate cancer by
biopsy are removed from the study.
- Arm II: Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy.
Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I.
Patients with no HGPIN or prostate cancer by biopsy are removed from the study.
After completion of study treatment, patients are followed annually for 2 years.
PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Presence of prostate intraepithelial neoplasia after 16 weeks
Robert S. DiPaola, MD
Cancer Institute of New Jersey
United States: Institutional Review Board
|Overlook Hospital||Summit, New Jersey 07902-0220|
|Carol G. Simon Cancer Center at Morristown Memorial Hospital||Morristown, New Jersey 07962|
|Saint Peter's University Hospital||New Brunswick, New Jersey 08901-1780|
|Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School||New Brunswick, New Jersey 08903|
|Central Jersey Oncology Center, PA - East Brunswick||East Brunswick, New Jersey 08816|