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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Virga Jesse Hospital
Hasselt, Belgium
U.Z. Gasthuisberg
Leuven, Belgium
Istituto Scientifico H. San Raffaele
Milan, Italy
Ospedale di Circolo e Fondazione Macchi
Varese, Italy
Martin Faculty Hospital
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Martin, Slovakia