Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00022412
• Other study ID #: CO99802
• Secondary ID: P30CA014520WCCC-
• Status: Completed
• Phase: Phase 2
• Start date: August 2001
• Est. completion date: August 2008

Study information

• Verified date: October 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2008
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Procedure:
• conventional surgery
Procedure: Prostatectomy for prostate cancer

Locations

Country	Name	City	State
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Meriter Hospital	Madison	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Veterans Affairs Medical Center - Madison	Madison	Wisconsin
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intermediate endpoint biomarker modulation		18 months
Primary	Toxicity		30 months

External Links

•   University of Wisconsin Carbone Cancer Center