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.

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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.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00022412

Recruitment Status:

Completed

Sponsor:

University of Wisconsin, Madison

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There are 6 Locations for this study

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Holden Comprehensive Cancer Center at University of Iowa
Iowa City Iowa, 52242, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester New York, 14642, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
Meriter Hospital
Madison Wisconsin, 53715, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT00022412

Recruitment Status:

Completed

Sponsor:


University of Wisconsin, Madison

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