Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
NCT00118066 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2015-05-27
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.
Conditions
- Precancerous/Nonmalignant Condition
- Prostate Cancer
Interventions
- DIETARY_SUPPLEMENT
-
calcitriol
Given orally
- PROCEDURE
-
observation
No initial intervention
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Rutgers Cancer Institute of New Jersey
collaborator OTHER -
Rutgers, The State University of New Jersey
lead OTHER
Principal Investigators
-
Robert S. DiPaola, MD · Rutgers Cancer Institute of New Jersey
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-05-31
- Primary Completion
- 2011-06-30
- Completion
- 2011-08-31
Countries
- United States
Study Locations
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