Viewing Study NCT00118066



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Last Modification Date: 2024-10-26 @ 9:12 AM
Study NCT ID: NCT00118066
Status: TERMINATED
Last Update Posted: 2015-05-27
First Post: 2005-07-08

Brief Title: Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
Sponsor: Rutgers The State University of New Jersey
Organization: Rutgers The State University of New Jersey

Study Overview

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
CINJ-NJ3803 Other Identifier CINJ IRB httpsreporternihgovquickSearchP30CA072720
P30CA072720 NIH None None
CDR0000433508 OTHER None None
0220044901 OTHER None None