Clinical Trial: Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia

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 Summary:

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.


Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome: Presence of prostate intraepithelial neoplasia after 16 weeks [ Time Frame: 4 years ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: July 8, 2005
Date Started: May 2004
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2015