Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT00027794
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
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 investigator's 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 investigator's 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:
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 ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| EORTC-30001 | None | None | View |