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Brief Title: Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer
Official Title: Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study
Study ID: NCT00027794
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.
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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Virga Jesse Hospital, Hasselt, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Istituto Scientifico H. San Raffaele, Milano, , Italy
Ospedale di Circolo e Fondazione Macchi, Varese, , Italy
Martin Faculty Hospital, Martin, , Slovakia
Name: Hein van Poppel, MD, PhD
Affiliation: University Hospital, Gasthuisberg
Role: STUDY_CHAIR