Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027794
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-12-07
Brief Title:
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Radical Prostatectomy for Locally Advanced Prostate Cancer A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2012-09
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 Radical prostatectomy may be an effective treatment for locally advanced prostate cancer
PURPOSE Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer
PURPOSE Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer
Detailed Description:
OBJECTIVES
Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate
Determine the serious toxic event rate of this surgery in these patients
Determine the pN status of patients treated with this surgery
Determine the percentage of patients found to have organ-confined tumors pT2 after undergoing this surgery
Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery
Determine the surgical morbidity rates of patients treated with this surgery
OUTLINE This is a multicenter study
Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy
Patients who are found to have pN-positive disease receive further treatment according to the investigators discretion Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year
PROJECTED ACCRUAL A total of 32-74 patients will be accrued for this study
Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate
Determine the serious toxic event rate of this surgery in these patients
Determine the pN status of patients treated with this surgery
Determine the percentage of patients found to have organ-confined tumors pT2 after undergoing this surgery
Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery
Determine the surgical morbidity rates of patients treated with this surgery
OUTLINE This is a multicenter study
Patients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy
Patients who are found to have pN-positive disease receive further treatment according to the investigators discretion Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year
PROJECTED ACCRUAL A total of 32-74 patients will be accrued for this study
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 |
|---|---|---|---|
| EORTC-30001 | None | None | None |