Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00078910
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2004-03-08
Brief Title:
Neoadjuvant Exisulind in Treating Patients Who Are Undergoing Radical Prostatectomy for Stage II or Stage III Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Prospective Phase II Study of Preoperative Controlled Exisulind Therapy Initiated Prior to Radical Prostatectomy Effect on Apoptosis
Status:
COMPLETED
Status Verified Date:
2006-09
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 Drugs used in chemotherapy such as exisulind work in different ways to stop tumor cells from dividing so they stop growing or die Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well neoadjuvant exisulind works in treating patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer
PURPOSE This phase II trial is studying how well neoadjuvant exisulind works in treating patients who are undergoing radical prostatectomy for stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES
Primary
Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in patients with stage II or III prostate cancer undergoing radical prostatectomy
Secondary
Determine the effect of this drug preoperatively on surrogate endpoint biomarkers ie prostate-specific antigen high-grade prostatic intraepithelial neoplasia MIB-1 and DNA ploidy in these patients
OUTLINE This is a nonrandomized controlled study Patients are assigned to 1 of 2 groups based on the treating physician
Control group Patients undergo radical prostatectomy only
Treatment group Patients receive oral exisulind once daily for 4 weeks Patients then undergo radical prostatectomy
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 130 patients 65 per group will be accrued for this study within approximately 10-12 months
Primary
Compare the effect of neoadjuvant exisulind vs no neoadjuvant treatment on apoptosis in patients with stage II or III prostate cancer undergoing radical prostatectomy
Secondary
Determine the effect of this drug preoperatively on surrogate endpoint biomarkers ie prostate-specific antigen high-grade prostatic intraepithelial neoplasia MIB-1 and DNA ploidy in these patients
OUTLINE This is a nonrandomized controlled study Patients are assigned to 1 of 2 groups based on the treating physician
Control group Patients undergo radical prostatectomy only
Treatment group Patients receive oral exisulind once daily for 4 weeks Patients then undergo radical prostatectomy
Patients are followed at 1 month
PROJECTED ACCRUAL A total of 130 patients 65 per group will be accrued for this study within approximately 10-12 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| MAYO-229701 | None | None | None |