Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
This trial is active, not recruiting.
|Treatments||doxercalciferol, conventional surgery|
|Sponsor||University of Wisconsin, Madison|
|Collaborator||National Cancer Institute (NCI)|
|Start date||August 2001|
|End date||February 2006|
|Trial size||60 participants|
|Trial identifier||NCT00022412, 2000-595, CDR0000068813, NCI-N01-CN-95130, NCI-P01-0188, P30CA014520, WCCC-CO-2000169, WCCC-CO-99802|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Iowa City, IA||Holden Comprehensive Cancer Center at University of Iowa||no longer recruiting|
|Rochester, NY||James P. Wilmot Cancer Center at University of Rochester Medical Center||no longer recruiting|
|Madison, WI||Meriter Hospital||no longer recruiting|
|Madison, WI||University of Wisconsin Comprehensive Cancer Center||no longer recruiting|
|Madison, WI||Veterans Affairs Medical Center - Madison||no longer recruiting|
|Milwaukee, WI||Medical College of Wisconsin Cancer Center||no longer recruiting|
|Intervention model||parallel assignment|
Intermediate endpoint biomarker modulation
time frame: 18 months
time frame: 30 months
Male participants from 21 years up to 120 years old.
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
|Official title||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|
|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.|
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