Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: doxercalciferol
* Procedure: conventional surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Observation, then prostatectomy<br>Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy. | Procedure: conventional surgery<br>* Procedure: Prostatectomy for prostate cancer<br>* Other names: Prostatectomy - no dietary supplement;|
| Active Comparator: Doxercalciferol once daily for 28 days<br>Dietary supplement once daily to treat prostate cancer for 28 days | Dietary Supplement: doxercalciferol<br>* Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.<br>* Other names: Localized adenocarcinoma of the prostate;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intermediate endpoint biomarker modulation |  | 18 months | 
| Toxicity |  | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer