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Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

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ClinicalTrials.gov Identifier: NCT00118066
Recruitment Status : Terminated (Slow accruaL, lack of scientific progress)
First Posted : July 11, 2005
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Rutgers Cancer Institute of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey

Tracking Information
First Submitted Date  ICMJE July 8, 2005
First Posted Date  ICMJE July 11, 2005
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE May 2004
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2011)
Presence of prostate intraepithelial neoplasia after 16 weeks [ Time Frame: 4 years ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00118066 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
Official Title  ICMJE A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Precancerous/Nonmalignant Condition
  • Prostate Cancer
Intervention  ICMJE
  • Dietary Supplement: calcitriol
    Given orally
  • Procedure: observation
    No initial intervention
Study Arms  ICMJE
  • 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
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 9, 2011)
12
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00118066
Other Study ID Numbers  ICMJE 080404
P30CA072720 ( U.S. NIH Grant/Contract )
CDR0000433508 ( Other Identifier: NIH )
0220044901 ( Other Identifier: CINJ IRB )
CINJ-NJ3803
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
Investigators  ICMJE
Principal Investigator: Robert S. DiPaola, MD Rutgers Cancer Institute of New Jersey
PRS Account Rutgers, The State University of New Jersey
Verification Date May 2015

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