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

January 2, 2023 updated by: University Hospital, Ghent
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Ghent University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men who were surgically treated or who are being surgically treated for prostate cancer.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Radical Retropubic prostatectomy (RRP)
Men who underwent open radical prostatectomy in the past at our centre.
Robot-assisted laparoscopic prostatectomy (RALP)
Men who undergo robot-assisted laparoscopic prostatectomy at our centre.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical recurrence at follow-up.
Time Frame: 3 months after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
3 months after prostatectomy
Biochemical recurrence at follow-up
Time Frame: 6 months after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
6 months after prostatectomy
Biochemical recurrence at follow-up.
Time Frame: 9 months after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
9 months after prostatectomy
Biochemical recurrence at follow-up.
Time Frame: 1 year after prostatectomy
PSA measurement in the serum should not be > or = 0,20 ng/ml.
1 year after prostatectomy
Biochemical recurrence at follow-up.
Time Frame: 6-monthly follow up between 1 and 5 years after prostatectomy.
PSA measurement in the serum should not be > or = 0,20 ng/ml.
6-monthly follow up between 1 and 5 years after prostatectomy.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional assessment concerning continence.
Time Frame: 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.
after 1, 3, 12 and 24 months
Functional assessment concerning potency.
Time Frame: 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.
after 1, 3, 12 and 24 months
Functional assessment concerning quality of life.
Time Frame: 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.
after 1, 3, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Nicolaas Lumen, MD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

October 31, 2011

Study Completion (Actual)

October 31, 2012

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

April 13, 2012

First Posted (Estimate)

April 16, 2012

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 2, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/122

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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