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A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia

Phase 2
18 Years
Not Enrolling
Precancerous/Nonmalignant Condition, Prostate Cancer

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Trial Information

A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia


- 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.

Inclusion Criteria


- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- SGOT and SGPT ≤ 1.5 times upper limit of normal


- No uncontrolled renal failure

- No cancer-related hypercalcemia or kidney stones within the past 5 years


- No uncontrolled coronary artery disease

- No uncontrolled congestive heart failure


- 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


Biologic therapy

- Not specified


- 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


- Not specified


- Not specified


- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Presence of prostate intraepithelial neoplasia after 16 weeks

Outcome Time Frame:

4 years

Safety Issue:


Principal Investigator

Robert S. DiPaola, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Institutional Review Board

Study ID:




Start Date:

May 2004

Completion Date:

June 2011

Related Keywords:

  • Precancerous/Nonmalignant Condition
  • Prostate Cancer
  • prostate cancer
  • high grade prostatic intraepithelial neoplasia
  • Neoplasms
  • Precancerous Conditions
  • Prostatic Neoplasms
  • Prostatic Intraepithelial Neoplasia
  • Carcinoma in Situ



Overlook Hospital Summit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown, New Jersey  07962
Saint Peter's University Hospital New Brunswick, New Jersey  08901-1780
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick, New Jersey  08903
Central Jersey Oncology Center, PA - East Brunswick East Brunswick, New Jersey  08816