Doxercalciferol Before Surgery in Treating Localized Prostate Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

August 10, 2001

Last Updated Date

February 6, 2009

Start Date ^†

August 2001

Current Primary Outcome Measures ^†

Intermediate endpoint biomarker modulation [ Designated as safety issue: No ]
Toxicity [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^†

Intermediate endpoint biomarker modulation
Toxicity

Change History

Complete list of historical versions of study NCT00022412 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

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

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 1 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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control

Condition ^†

Prostate Cancer

Intervention ^†

Dietary Supplement: doxercalciferol
Procedure: conventional surgery

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Completion Date

Primary Completion Date

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

Gender

Male

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00022412

Responsible Party

Secondary IDs ^††

WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188

Study Sponsor ^†

University of Wisconsin, Madison

Collaborators ^††

National Cancer Institute (NCI)

Investigators ^†

Study Chair:

George Wilding, MD

University of Wisconsin, Madison

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.