Prostate Cancer Clinical Trial
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Summary
RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.
PURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.
Full Description
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.
Eligibility 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
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There are 6 Locations for this study
Iowa City Iowa, 52242, United States
Rochester New York, 14642, United States
Madison Wisconsin, 53705, United States
Madison Wisconsin, 53715, United States
Madison Wisconsin, 53792, United States
Milwaukee Wisconsin, 53226, United States
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