Doxercalciferol Before Surgery in Treating Localized Prostate Cancer - Full Text View

Sponsor:	University of Wisconsin, Madison
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00022412

Purpose

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	Intervention	Phase
Prostate Cancer	Dietary Supplement: doxercalciferol Procedure: conventional surgery	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Prostate Cancer

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Intermediate endpoint biomarker modulation [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Toxicity [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	August 2001
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: Localized adenocarcinoma of the prostate

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.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022412

Locations

United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, New York
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, United States, 14642
United States, Wisconsin
Meriter Hospital
Madison, Wisconsin, United States, 53715
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226-3596

Sponsors and Collaborators

University of Wisconsin, Madison

National Cancer Institute (NCI)

Investigators

Study Chair:

George Wilding, MD

University of Wisconsin, Madison

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	George Wilding, MD, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT00022412 History of Changes
Other Study ID Numbers:	CDR0000068813, P30CA014520, WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188
Study First Received:	August 10, 2001
Last Updated:	March 28, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Wisconsin, Madison:

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

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
1 alpha-hydroxyergocalciferol

Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 12, 2012