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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

July 8, 2005
June 13, 2012
May 2004
June 2011   (final data collection date for primary outcome measure)
Presence of prostate intraepithelial neoplasia after 16 weeks [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00118066 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Precancerous/Nonmalignant Condition
  • Prostate Cancer
  • Dietary Supplement: calcitriol
    Given orally
  • Procedure: observation
    No initial intervention
  • 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.
    Intervention: Dietary Supplement: calcitriol
  • 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.
    Interventions:
    • Dietary Supplement: calcitriol
    • Procedure: observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00118066
080404, P30CA072720, CDR0000433508, 0220044901, CINJ-NJ3803
No
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
University of Medicine and Dentistry of New Jersey
National Cancer Institute (NCI)
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
Rutgers, The State University of New Jersey
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP