NCT00022412

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2001

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

August 10, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2006

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

December 13, 2019

Status Verified

October 1, 2016

Enrollment Period

4.5 years

First QC Date

August 10, 2001

Last Update Submit

December 11, 2019

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage II prostate cancer

Outcome Measures

Primary Outcomes (2)

  • Intermediate endpoint biomarker modulation

    18 months

  • Toxicity

    30 months

Study Arms (2)

Observation, then prostatectomy

PLACEBO COMPARATOR

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

Procedure: conventional surgery

Doxercalciferol once daily for 28 days

ACTIVE COMPARATOR

Dietary supplement once daily to treat prostate cancer for 28 days

Dietary Supplement: doxercalciferol

Interventions

doxercalciferolDIETARY_SUPPLEMENT

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

Also known as: Localized adenocarcinoma of the prostate
Doxercalciferol once daily for 28 days
conventional surgeryPROCEDURE

Procedure: Prostatectomy for prostate cancer

Also known as: Prostatectomy - no dietary supplement
Observation, then prostatectomy

Eligibility Criteria

Age21 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1002, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Veterans Affairs Medical Center - Madison

Madison, Wisconsin, 53705, United States

Location

Meriter Hospital

Madison, Wisconsin, 53715, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Medical College of Wisconsin Cancer Center

Milwaukee, Wisconsin, 53226-3596, United States

Location

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

1 alpha-hydroxyergocalciferol

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • George Wilding, MD

    University of Wisconsin, Madison

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2001

First Posted

January 27, 2003

Study Start

August 1, 2001

Primary Completion

February 1, 2006

Study Completion

August 1, 2008

Last Updated

December 13, 2019

Record last verified: 2016-10

Locations

US(6)