Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study|
|Study Start Date:||September 2001|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00027794
|Virga Jesse Hospital|
|Hasselt, Belgium, 3500|
|Leuven, Belgium, B-3000|
|Istituto Scientifico H. San Raffaele|
|Milano, Italy, 20132|
|Ospedale di Circolo e Fondazione Macchi|
|Varese, Italy, 21100|
|Martin Faculty Hospital|
|Martin, Slovakia, 03659|
|Study Chair:||Hein van Poppel, MD, PhD||U.Z. Gasthuisberg|