Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

This study has been terminated.
(Slow accruaL, lack of scientific progress)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00118066
First received: July 8, 2005
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Precancerous/Nonmalignant Condition
Prostate Cancer
Dietary Supplement: calcitriol
Procedure: observation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Presence of prostate intraepithelial neoplasia after 16 weeks [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2004
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118066

Locations
United States, New Jersey
Central Jersey Oncology Center, PA - East Brunswick
East Brunswick, New Jersey, United States, 08816
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07901
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
  More Information

No publications provided

Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00118066     History of Changes
Other Study ID Numbers: 080404, P30CA072720, CDR0000433508, 0220044901, CINJ-NJ3803
Study First Received: July 8, 2005
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
prostate cancer
high grade prostatic intraepithelial neoplasia

Additional relevant MeSH terms:
Neoplasms
Precancerous Conditions
Prostatic Neoplasms
Prostatic Intraepithelial Neoplasia
Carcinoma in Situ
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Calcitriol
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014