Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00022412|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 11, 2016
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|
- 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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- Intermediate endpoint biomarker modulation [ Time Frame: 18 months ]
- Toxicity [ Time Frame: 30 months ]
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 ClinicalTrials.gov 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|
|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|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|