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Sponsors and Collaborators: |
University of Wisconsin, Madison National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00022412 |
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 |
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Prostate Cancer |
Dietary Supplement: doxercalciferol Procedure: conventional surgery |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control |
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 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1 of 2 arms.
PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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 | |
Medical College of Wisconsin Cancer Center | |
Milwaukee, Wisconsin, United States, 53226-3596 | |
Veterans Affairs Medical Center - Madison | |
Madison, Wisconsin, United States, 53705 | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-6164 | |
Meriter Hospital | |
Madison, Wisconsin, United States, 53715 |
Study Chair: | George Wilding, MD | University of Wisconsin, Madison |
Study ID Numbers: | CDR0000068813, WCCC-CO-99802, NCI-N01-CN-95130, WCCC-CO-2000169, NCI-P01-0188 |
Study First Received: | August 10, 2001 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00022412 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
1 alpha-hydroxyergocalciferol Prostatic Diseases Genital Neoplasms, Male Vitamins Bone Density Conservation Agents Trace Elements |
Urogenital Neoplasms Micronutrients Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Hydroxycholecalciferols |
Genital Neoplasms, Male Prostatic Diseases Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents Urogenital Neoplasms Genital Diseases, Male |
Pharmacologic Actions Neoplasms Neoplasms by Site 1 alpha-hydroxyergocalciferol Vitamins Micronutrients Prostatic Neoplasms |