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Last Modified: 1/30/2009     First Published: 6/25/2005  
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Phase II Randomized Chemoprevention Study of Calcitriol in Patients With High-Grade Prostatic Intraepithelial Neoplasia

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIPreventionClosed18 and overNCICINJ-080404
NJ 3803, CINJ-4901, CINJ-NJ3803, CINJ-5111, NCT00118066

Objectives

  1. Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia.
  2. Determine the toxicity of this drug in these patients.
  3. Determine the effect of this drug on prostate specific antigen in these patients.

Entry Criteria

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


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

Patient Characteristics:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm3
  • Platelet count ≥ 100,000/mm3

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

Expected Enrollment

50

A total of 50 patients (25 per arm) will be accrued for this study.

Outcomes

Primary Outcome(s)

Presence of prostate intraepithelial neoplasia after 16 weeks

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.

Trial Contact Information

Trial Lead Organizations

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Robert DiPaola, MD, Principal investigator
Ph: 732-235-7414

Registry Information
Official Title A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
Trial Start Date 2004-05-04
Trial Completion Date 2008-12-31 (estimated)
Registered in ClinicalTrials.gov NCT00118066
Date Submitted to PDQ 2005-05-17
Information Last Verified 2009-01-30
NCI Grant/Contract Number CA72720

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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