Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2008-08-31

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.

Conditions

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Prostate Cancer

Keywords

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adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Observation, then prostatectomy

Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

Group Type PLACEBO_COMPARATOR

conventional surgery

Intervention Type PROCEDURE

Procedure: Prostatectomy for prostate cancer

Doxercalciferol once daily for 28 days

Dietary supplement once daily to treat prostate cancer for 28 days

Group Type ACTIVE_COMPARATOR

doxercalciferol

Intervention Type DIETARY_SUPPLEMENT

Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.

Interventions

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doxercalciferol

Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.

Intervention Type DIETARY_SUPPLEMENT

conventional surgery

Procedure: Prostatectomy for prostate cancer

Intervention Type PROCEDURE

Other Intervention Names

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Localized adenocarcinoma of the prostate Prostatectomy - no dietary supplement

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

120 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Wilding, MD

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

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Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, United States

Site Status

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, United States

Site Status

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, United States

Site Status

Meriter Hospital

Madison, Wisconsin, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States