Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00027794|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : September 24, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Procedure: conventional surgery||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Masking:||None (Open Label)|
|Official Title:||Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||January 2005|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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||University Hospital, Gasthuisberg|