Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT00022412

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Dietary Supplement: doxercalciferol Procedure: conventional surgery	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Feb 1, 2006

Actual Study Completion Date :

Aug 1, 2008

Arms and Interventions

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

Arm

Intervention/Treatment

Placebo Comparator: Observation, then prostatectomy

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

Procedure: conventional surgery

Procedure: Prostatectomy for prostate cancer

Other Names:

Prostatectomy - no dietary supplement

Active Comparator: Doxercalciferol once daily for 28 days

Dietary supplement once daily to treat prostate cancer for 28 days

Dietary Supplement: doxercalciferol

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

Other Names:

Localized adenocarcinoma of the prostate

Outcome Measures

Primary Outcome Measures

Intermediate endpoint biomarker modulation [18 months]
Toxicity [30 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 120 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa	United States	52242-1002
2	James P. Wilmot Cancer Center at University of Rochester Medical Center	Rochester	New York	United States	14642
3	Veterans Affairs Medical Center - Madison	Madison	Wisconsin	United States	53705
4	Meriter Hospital	Madison	Wisconsin	United States	53715
5	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin	United States	53792-6164
6	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin	United States	53226-3596