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. (see Contacts and Locations)
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

April 12, 2012
February 1, 2013
February 2013
April 2016   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01578356 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
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Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Prostate Cancer
Not Provided
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
April 2016
April 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

-

Male
18 Years and older
No
Contact: Nicolaas Lumen, MD Nicolaas.Lumen@uzgent.be
Belgium
 
NCT01578356
2012/122
No
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Nicolaas Lumen, MD Ghent University Hospital
University Hospital, Ghent
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP