A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
18 Years
N/A
Male
Precancerous/Nonmalignant Condition, Prostate Cancer
Trial Information
A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia
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.
Inclusion 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
Type of Study:
Interventional
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:
No
Principal Investigator
Robert S. DiPaola, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Institutional Review Board
Study ID:
080404
NCT ID:
NCT00118066
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
Name | Location |
|---|---|
| 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 |
