Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

May 22, 2015 updated by: Rutgers, The State University of New Jersey

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • Central Jersey Oncology Center, PA - East Brunswick
      • Morristown, New Jersey, United States, 07962
        • Carol G. Simon Cancer Center at Morristown Memorial Hospital
      • New Brunswick, New Jersey, United States, 08903
        • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
      • New Brunswick, New Jersey, United States, 08903
        • Saint Peter's University Hospital
      • Summit, New Jersey, United States, 07901
        • Overlook Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-grade prostatic intraepithelial neoplasia

    • Diagnosed within the past 6 months
  • No evidence of prostate cancer within the past 6 months
  • No evidence of palpable nodules on digital rectal exam
  • Prostate specific antigen ≤ 10 ng/mL within the past 3 months

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • SGOT and SGPT ≤ 1.5 times upper limit of normal

Renal

  • No uncontrolled renal failure
  • No cancer-related hypercalcemia or kidney stones within the past 5 years

Cardiovascular

  • No uncontrolled coronary artery disease
  • No uncontrolled congestive heart failure

Other

  • Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer
  • No known HIV positivity
  • No active infection
  • No major depression or suicidal ideation
  • No other condition that would preclude study compliance
  • No other uncontrolled medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy for any malignancy

Endocrine therapy

  • At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor
  • No concurrent corticosteroids

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • At least 2 weeks since prior phenytoin or phenobarbital
  • At least 2 weeks since prior ketoconazole

  • No concurrent administration of any of the following:

    • Magnesium-containing antacids
    • Thiazide diuretics
    • Calcium supplements
    • Digoxin
    • Herbal supplements
    • Pharmacological doses of cholecalciferol (vitamin D) or its derivatives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I
Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses. 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.
Dietary supplement: calcitriol
Given orally
Other: 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.
Dietary supplement: calcitriol
Given orally
Procedure: observation
No initial intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of prostate intraepithelial neoplasia after 16 weeks
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey

Investigators

  • Principal Investigator: Robert S. DiPaola, MD, Rutgers Cancer Institute of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 8, 2005

First Submitted That Met QC Criteria

July 8, 2005

First Posted (Estimate)

July 11, 2005

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080404
  • P30CA072720 (U.S. NIH Grant/Contract)
  • CDR0000433508 (Other Identifier: NIH)
  • 0220044901 (Other Identifier: CINJ IRB)
  • CINJ-NJ3803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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