Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00022412
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 11, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: doxercalciferol Procedure: conventional surgery Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Estimated 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 : August 2001
Actual Primary Completion Date : February 2006
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

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 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

Primary Outcome Measures :
  1. Intermediate endpoint biomarker modulation [ Time Frame: 18 months ]
  2. Toxicity [ Time Frame: 30 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   21 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed localized adenocarcinoma of the prostate
  • Candidate for prostatectomy



  • 21 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.4 mg/dL
  • AST no greater than 3 times normal


  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 10.2 mg/dL
  • No idiopathic urinary calcium stone disease


Biologic therapy:

  • Not specified


  • 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


  • No prior brachytherapy or external beam radiotherapy for prostate cancer


  • See Disease Characteristics


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00022412

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
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
Meriter Hospital
Madison, Wisconsin, United States, 53715
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)
Study Chair: George Wilding, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00022412     History of Changes
Other Study ID Numbers: 2000-595
P30CA014520 ( U.S. NIH Grant/Contract )
CDR0000068813 ( Other Identifier )
CO99802 ( Other Identifier: University of Wisconsin Carbone Cancer Center )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016

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
Genital Diseases, Male
Prostatic Diseases
1 alpha-hydroxyergocalciferol
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents