Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer

Prostate Cancer Clinical Trial

Official title: Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT00027794
• Study type: Interventional
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Status: Completed
• Phase: Phase 2
• Start date: September 2001