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Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
doxercalciferol
conventional surgery
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

Eligibility Criteria

21 Years - 120 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Holden Comprehensive Cancer Center at University of Iowa
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Veterans Affairs Medical Center - Madison
  • Meriter Hospital
  • University of Wisconsin Comprehensive Cancer Center
  • Medical College of Wisconsin Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Observation, then prostatectomy

Doxercalciferol once daily for 28 days

Arm Description

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

Dietary supplement once daily to treat prostate cancer for 28 days

Outcomes

Primary Outcome Measures

Intermediate endpoint biomarker modulation
Toxicity

Secondary Outcome Measures

Full Information

First Posted
August 10, 2001
Last Updated
December 11, 2019
Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00022412
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
February 2006 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage II prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Observation, then prostatectomy
Arm Type
Placebo Comparator
Arm Description
Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.
Arm Title
Doxercalciferol once daily for 28 days
Arm Type
Active Comparator
Arm Description
Dietary supplement once daily to treat prostate cancer for 28 days
Intervention Type
Dietary Supplement
Intervention Name(s)
doxercalciferol
Other Intervention Name(s)
Localized adenocarcinoma of the prostate
Intervention Description
Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Other Intervention Name(s)
Prostatectomy - no dietary supplement
Intervention Description
Procedure: Prostatectomy for prostate cancer
Primary Outcome Measure Information:
Title
Intermediate endpoint biomarker modulation
Time Frame
18 months
Title
Toxicity
Time Frame
30 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Wilding, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Study Chair
Facility Information:
Facility Name
Holden Comprehensive Cancer Center at University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242-1002
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Veterans Affairs Medical Center - Madison
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Meriter Hospital
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792-6164
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3596
Country
United States

12. IPD Sharing Statement

Links:
URL
https://cancer.wisc.edu/
Description
University of Wisconsin Carbone Cancer Center

Learn more about this trial

Doxercalciferol Before Surgery in Treating Localized Prostate Cancer

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