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

Sponsors and Collaborators:	Cancer Institute of New Jersey National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
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	Drug: calcitriol Procedure: observation	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Calcitriol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Active Control
Official Title:	A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Presence of prostate intraepithelial neoplasia after 16 weeks [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	May 2004
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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.	Drug: calcitriol Given orally
Arm II: No Intervention 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.	Drug: calcitriol Given orally Procedure: observation No initial intervention

Arms

Assigned Interventions

Arm I: Experimental

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.

Drug: calcitriol

Given orally

Arm II: No Intervention

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.

Drug: 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
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Overlook Hospital
Summit, New Jersey, United States, 07901
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08903
University Medical Center at Princeton
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Cancer Institute of New Jersey

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Robert S. DiPaola, MD

Cancer Institute of New Jersey

More Information

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

Responsible Party:	Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School ( Robert S. DiPaola )
Study ID Numbers:	CDR0000433508, CINJ-080404, CINJ-4901, CINJ-NJ3803, CINJ-5111
Study First Received:	July 8, 2005
Last Updated:	October 25, 2008
ClinicalTrials.gov Identifier:	NCT00118066
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

prostate cancer
high grade prostatic intraepithelial neoplasia

Study placed in the following topic categories:

Prostatic Intraepithelial Neoplasia
Calcium, Dietary
Prostatic Diseases
Genital Neoplasms, Male
Precancerous Conditions
Carcinoma in Situ

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms
Calcitriol
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Calcium Channel Agonists
Bone Density Conservation Agents
Cardiovascular Agents
Pharmacologic Actions

Membrane Transport Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Vasoconstrictor Agents
Micronutrients

ClinicalTrials.gov processed this record on January 16, 2009