Text Size

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

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01578356
First received: April 12, 2012
Last updated: February 1, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Biochemical recurrence at follow-up. [ Time Frame: 3 months after prostatectomy ] [ Designated as safety issue: No ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • Biochemical recurrence at follow-up [ Time Frame: 6 months after prostatectomy ] [ Designated as safety issue: No ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • Biochemical recurrence at follow-up. [ Time Frame: 9 months after prostatectomy ] [ Designated as safety issue: No ]
    PSA measurement in the serum should not be > or = 0,20 ng/ml.

  • Biochemical recurrence at follow-up. [ Time Frame: 1 year after prostatectomy ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578356

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

Locations
Belgium
Ghent University Hospital Not yet 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 Ghent University Hospital
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01578356     History of Changes
Other Study ID Numbers: 2012/122
Study First Received: April 12, 2012
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on May 23, 2013