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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
April 12, 2012
April 16, 2012
December 5, 2014
February 2013
April 2016   (Final data collection date for primary outcome measure)
  • 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.
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 ]
    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.
Same as current
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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.
 
Unknown status
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:

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01578356
2012/122
No
Not Provided
Not Provided
University Hospital, Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Nicolaas Lumen, MD University Hospital, Ghent
University Hospital, Ghent
December 2014