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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01578356
First Posted: April 16, 2012
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Ghent
  Purpose
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.

Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Biochemical recurrence at follow-up. [ Time Frame: 3 months after prostatectomy ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • Biochemical recurrence at follow-up [ Time Frame: 6 months after prostatectomy ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • Biochemical recurrence at follow-up. [ Time Frame: 9 months after prostatectomy ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • Biochemical recurrence at follow-up. [ Time Frame: 1 year after prostatectomy ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.

  • 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.


Estimated Enrollment: 50
Study Start Date: February 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men who were surgically treated or who are being surgically treated for prostate cancer.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01578356


Contacts
Contact: Nicolaas Lumen, MD Nicolaas.Lumen@uzgent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Contact: Nicolaas Lumen, MD       Nicolaas.Lumen@uzgent.be   
Principal Investigator: Nicolaas Lumen, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Nicolaas Lumen, MD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01578356     History of Changes
Other Study ID Numbers: 2012/122
First Submitted: April 12, 2012
First Posted: April 16, 2012
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
Prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases