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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 29, 2014