Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT01578356
• Lead Sponsor: University Hospital, Ghent

Brief Summary

For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Primary Completion: 2011-10-31
• Study First Submitted: 2012-04-12
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Study Completion: 2012-10-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-02
• Last Update Posted: 2023-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• prostate cancer
• radical retropubic prostatectomy or
• robot-assisted laparoscopic surgery

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical recurrence at follow-up	6 months after prostatectomy	PSA measurement in the serum should not be \> or = 0,20 ng/ml.
Biochemical recurrence at follow-up.	6-monthly follow up between 1 and 5 years after prostatectomy.	PSA measurement in the serum should not be \> or = 0,20 ng/ml.

Secondary Outcome Measures

Name	Time	Method
Functional assessment concerning potency.	after 1, 3, 12 and 24 months	Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Functional assessment concerning continence.	after 1, 3, 12 and 24 months	Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.
Functional assessment concerning quality of life.	after 1, 3, 12 and 24 months	Patients need to fill out questionnaires (EORTC QLQ-C30, QLQ-PR25, ICIQ mLUTS and UI SF and IIEF). The patients in the radical retropubic prostatectomy group only fill out the questionnaires once.

Trial Locations

Locations (1)

Ghent University Hospital; 🇧🇪 Ghent, Belgium