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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: prostate cancer radical retropubic prostatectomy or robot-assisted laparoscopic surgery Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Radical Retropubic prostatectomy (RRP)<br>Men who underwent open radical prostatectomy in the past at our centre. | |
| Robot-assisted laparoscopic prostatectomy (RALP)<br>Men who undergo robot-assisted laparoscopic prostatectomy at our centre. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemical recurrence at follow-up. | PSA measurement in the serum should not be > or = 0,20 ng/ml. | 3 months after prostatectomy | 
| Biochemical recurrence at follow-up | PSA measurement in the serum should not be > or = 0,20 ng/ml. | 6 months after prostatectomy | 
| Biochemical recurrence at follow-up. | PSA measurement in the serum should not be > or = 0,20 ng/ml. | 9 months after prostatectomy | 
| Biochemical recurrence at follow-up. | PSA measurement in the serum should not be > or = 0,20 ng/ml. | 1 year after prostatectomy | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer