Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia

NCT00118066 | Terminated Phase 2

• 5 other identifiers: 080404P30CA072720CDR00004335080220044901CINJ-NJ3803
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

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.

Conditions

Precancerous/Nonmalignant Condition; Prostate Cancer

Keywords

prostate cancer; high grade prostatic intraepithelial neoplasia

Outcome Measures

Primary Outcomes (1)

• Presence of prostate intraepithelial neoplasia after 16 weeks

  4 years

Study Arms (2)

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.

Dietary Supplement: calcitriol

Arm II

OTHER

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; Procedure: observation

Interventions

calcitriol DIETARY_SUPPLEMENT

Given orally

Arm I; Arm II

observation PROCEDURE

No initial intervention

Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (5)

Central Jersey Oncology Center, PA - East Brunswick

East Brunswick, New Jersey, 08816, United States

Location

Carol G. Simon Cancer Center at Morristown Memorial Hospital

Morristown, New Jersey, 07962, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08903, United States

Location

Overlook Hospital

Summit, New Jersey, 07901, United States

Location

MeSH Terms

Conditions

Precancerous Conditions; Prostatic Neoplasms

Interventions

Calcitriol; Observation

Condition Hierarchy (Ancestors)

Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Methods; Investigative Techniques

Study Officials

• Robert S. DiPaola, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2005
• First Posted: July 11, 2005
• Study Start: May 1, 2004
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (5)