Official Title: A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
Status: TERMINATED
Status Verified Date: 2015-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Slow accruaL lack of scientific progress
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: RATIONALE Chemoprevention is the use of certain drugs to keep cancer from forming growing or coming back The use of calcitriol may prevent prostate cancer It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer
PURPOSE This randomized phase II trial is studying how well calcitriol works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia
Detailed Description: OBJECTIVES
Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia 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