Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
This study has been terminated.
(Slow accruaL, lack of scientific progress)
Sponsor:
University of Medicine and Dentistry New Jersey
Collaborator:
Information provided by (Responsible Party):
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00118066
First received: July 8, 2005
Last updated: June 13, 2012
Last verified: June 2012
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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 University of Medicine and Dentistry 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
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 New Jersey
Investigators
| Principal Investigator: | Robert S. DiPaola, MD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Medicine and Dentistry 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 University of Medicine and Dentistry 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 Vitamins Micronutrients Growth Substances Physiological Effects of Drugs Pharmacologic Actions Bone Density Conservation Agents Calcium Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013