Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
21 Years
N/A
Male
Prostate Cancer
Trial Information
Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN
OBJECTIVES:
- Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the
development of prostate cancer in patients with localized prostate cancer.
- Assess the toxicity of this drug in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one
of 2 arms.
- Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo
prostatectomy.
- Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within
18 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed localized adenocarcinoma of the prostate
- Candidate for prostatectomy
PATIENT CHARACTERISTICS:
Age:
- 21 and over
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.4 mg/dL
- AST no greater than 3 times normal
Renal:
- Creatinine no greater than 2.0 mg/dL
- Calcium no greater than 10.2 mg/dL
- No idiopathic urinary calcium stone disease
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- No prior hormonal therapy for prostate cancer
- No concurrent hormonal therapy, including luteinizing hormone-releasing hormone
agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride,
diethylstilbestrol, or progestins
Radiotherapy:
- No prior brachytherapy or external beam radiotherapy for prostate cancer
Surgery:
- See Disease Characteristics
Other:
- At least 7 days since prior vitamin D therapy or calcium supplements
- No other concurrent vitamin D analogues or calcium supplements
- No concurrent magnesium-containing antacids
- No concurrent thiazide-containing diuretics
- No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Intermediate endpoint biomarker modulation
Outcome Time Frame:
18 months
Safety Issue:
No
Principal Investigator
George Wilding, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Wisconsin, Madison
Authority:
United States: Federal Government
Study ID:
CDR0000068813
NCT ID:
NCT00022412
Start Date:
August 2001
Completion Date:
Related Keywords:
- Prostate Cancer
- adenocarcinoma of the prostate
- stage I prostate cancer
- stage II prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| Medical College of Wisconsin Cancer Center | Milwaukee, Wisconsin 53226 |
| Veterans Affairs Medical Center - Madison | Madison, Wisconsin 53705 |
| University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| James P. Wilmot Cancer Center at University of Rochester Medical Center | Rochester, New York 14642 |
| Meriter Hospital | Madison, Wisconsin 53715 |
