Quality of Life in Men Undergoing Robotic Assisted Laparoscopic Radical Prostatectomy Versus Radical Retropubic Prostatectomy

• Conditions: Prostatic Neoplasms; Quality of Life

• Registration Number: NCT01173952
• Lead Sponsor: Samsung Medical Center

Brief Summary

This study is prospective evaluation of quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus radical retropubic prostatectomy.

Detailed Description

Preoperatively, enrolled patients will complete questionnaires called EPIC that will ask about urinary, sexual, bowel and hormonal function

At 1, 3,6,9 and 12 months after surgery, pateints will complete the questionnaires again.

All will be enrolled at Samsung Medical Center

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-07-30
• Study First Submitted QC: 2010-07-30
• Last Update Submitted: 2010-07-30
• Study Start: 2010-08
• Study First Posted: 2010-08-02
• Last Update Posted: 2010-08-02
• Primary Completion: 2013-12
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 350

Inclusion Criteria

• Pathologic diagnosis of prostate adenocarcinoma
• Clinical stage: AJCC (VI) stage T1-T2 N0M0
• Primary treatment at Samsung Medical Center for prostate cancer using: radical retropubic prostatectomy, robotic prostatectomy

Exclusion Criteria

• Clinical Stage: T3, T4, nodal or distant metastasis
• All kind of neoadjuvant, concurrent and adjuvant treatment
• poor health forced a patient into dropout

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified