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

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ClinicalTrials.gov Identifier: NCT01578356
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : April 16, 2012
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

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.

Condition or disease
Prostate Cancer

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery
Study Start Date : February 2013
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Group/Cohort
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.



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

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

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

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

  5. 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 :
  1. 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.

  2. 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.

  3. 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.



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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:


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

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01578356     History of Changes
Other Study ID Numbers: 2012/122
First Posted: April 16, 2012    Key Record Dates
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