Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: doxercalciferol; Procedure: conventional surgery

• Registration Number: NCT00022412
• Lead Sponsor: University of Wisconsin, Madison

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-08
• Study First Submitted: 2001-08-10
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2006-02
• Study Completion: 2008-08
• Status Verified: 2016-10
• Last Update Submitted: 2019-12-11
• Last Update Posted: 2019-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Doxercalciferol once daily for 28 days	doxercalciferol	Dietary supplement once daily to treat prostate cancer for 28 days
Observation, then prostatectomy	conventional surgery	Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.

Primary Outcome Measures

Name	Time	Method
Intermediate endpoint biomarker modulation	18 months
Toxicity	30 months

Trial Locations

Locations (6)

Holden Comprehensive Cancer Center at University of Iowa; 🇺🇸 Iowa City, Iowa, United States

James P. Wilmot Cancer Center at University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Veterans Affairs Medical Center - Madison; 🇺🇸 Madison, Wisconsin, United States

Meriter Hospital; 🇺🇸 Madison, Wisconsin, United States

University of Wisconsin Comprehensive Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Medical College of Wisconsin Cancer Center; 🇺🇸 Milwaukee, Wisconsin, United States