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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578356
• Other study ID #: 2012/122
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: October 31, 2012

Study information

• Verified date: January 2023
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2012
• Est. primary completion date: October 31, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• prostate cancer

• radical retropubic prostatectomy or

• robot-assisted laparoscopic surgery

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Belgium	Ghent University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical recurrence at follow-up.	PSA measurement in the serum should not be > or = 0,20 ng/ml.	3 months after prostatectomy
Primary	Biochemical recurrence at follow-up	PSA measurement in the serum should not be > or = 0,20 ng/ml.	6 months after prostatectomy
Primary	Biochemical recurrence at follow-up.	PSA measurement in the serum should not be > or = 0,20 ng/ml.	9 months after prostatectomy
Primary	Biochemical recurrence at follow-up.	PSA measurement in the serum should not be > or = 0,20 ng/ml.	1 year after prostatectomy
Primary	Biochemical recurrence at follow-up.	PSA measurement in the serum should not be > or = 0,20 ng/ml.	6-monthly follow up between 1 and 5 years after prostatectomy.
Secondary	Functional assessment concerning continence.	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.	after 1, 3, 12 and 24 months
Secondary	Functional assessment concerning potency.	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.	after 1, 3, 12 and 24 months
Secondary	Functional assessment concerning quality of life.	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.	after 1, 3, 12 and 24 months

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