Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia - Full Text View

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00118066

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 II

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:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Calcitriol

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert S. DiPaola, MD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Robert S. DiPaola, Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier:	NCT00118066 History of Changes
Other Study ID Numbers:	CDR0000433508, P30CA072720, CINJ-080404, CINJ-4901, CINJ-NJ3803
Study First Received:	July 8, 2005
Last Updated:	May 9, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Medicine and Dentistry New Jersey:

prostate cancer
high grade prostatic intraepithelial neoplasia

Additional relevant MeSH terms:

Neoplasms
Disease
Precancerous Conditions
Prostatic Neoplasms
Prostatic Intraepithelial Neoplasia
Carcinoma in Situ
Pathologic Processes
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 February 09, 2012