NCT00027794

Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: European Organisation for Research and Treatment of Cancer - EORTC · Network
• Sex: Male
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
PROCEDURE	conventional surgery

Timeline

• Start date: 2001-09-01
• Primary completion: 2005-01-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

5 sites across 3 countries: Belgium, Italy, Slovakia