Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022412
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2001-08-10
Brief Title:
Doxercalciferol Before Surgery in Treating Localized Prostate Cancer
Sponsor:
University of Wisconsin Madison
Organization:
University of Wisconsin Madison
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2000-595 | OTHER | Institutional Review Board | httpsreporternihgovquickSearchP30CA014520 |
| P30CA014520 | NIH | None | None |
| WCCC-CO-99802 | None | None | None |
| NCI-N01-CN-95130 | None | None | None |
| WCCC-CO-2000169 | None | None | None |
| NCI-P01-0188 | None | None | None |
| CDR0000068813 | OTHER | None | None |