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Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

Primary Purpose

Precancerous/Nonmalignant Condition, Prostate Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
calcitriol
observation
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Precancerous/Nonmalignant Condition focused on measuring prostate cancer, high grade prostatic intraepithelial neoplasia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm I

Arm II

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence of prostate intraepithelial neoplasia after 16 weeks

Secondary Outcome Measures

Full Information

First Posted
July 8, 2005
Last Updated
May 22, 2015
Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT00118066
Brief Title
Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
Official Title
A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Slow accruaL, lack of scientific progress
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rutgers, The State University of New Jersey
Collaborators
National Cancer Institute (NCI), Rutgers Cancer Institute of New Jersey

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precancerous/Nonmalignant Condition, Prostate Cancer
Keywords
prostate cancer, high grade prostatic intraepithelial neoplasia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II
Arm Type
Other
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
calcitriol
Intervention Description
Given orally
Intervention Type
Procedure
Intervention Name(s)
observation
Intervention Description
No initial intervention
Primary Outcome Measure Information:
Title
Presence of prostate intraepithelial neoplasia after 16 weeks
Time Frame
4 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S. DiPaola, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Jersey Oncology Center, PA - East Brunswick
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States

12. IPD Sharing Statement

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Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

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