Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Launched by UNIVERSITY OF WISCONSIN, MADISON · Jan 26, 2003

Keywords

ClinConnect Summary

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...

Gender

MALE

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

Trial Officials