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Clinical Trials/NCT01578356
NCT01578356
Completed
Not Applicable

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

University Hospital, Ghent1 site in 1 country100 target enrollmentJanuary 1, 2009
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
University Hospital, Ghent
Enrollment
100
Locations
1
Primary Endpoint
Biochemical recurrence at follow-up
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2009
End Date
October 31, 2012
Last Updated
3 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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: 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 Outcomes

  • Functional assessment concerning potency.(after 1, 3, 12 and 24 months)
  • Functional assessment concerning continence.(after 1, 3, 12 and 24 months)
  • Functional assessment concerning quality of life.(after 1, 3, 12 and 24 months)

Study Sites (1)

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