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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

Phase Type Status Age Sponsor Protocol IDs
Phase II Prevention Closed 18 and over NCI CINJ-080404
NJ 3803, CINJ-4901, CINJ-NJ3803, CINJ-5111, NCT00118066

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.

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

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.