Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

Study Overview
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Brief Summary
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To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.

Detailed Description
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Background: Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR). Objective: To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model. Design, setting and participants: 100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study. Interventions: A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR. Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.

Official Title
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Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

Conditions
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Prostate Cancer

Intervention / Treatment
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* Procedure: 3D model guided secondary resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: preoperatively planed and intraoperatively performed nerve-sparing approach (at least unilateral) suitable pelvic MRI for the creation of a personalized 3D prostate model, written patient consent Exclusion Criteria: no nerve sparing performed

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Cohort Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D model guided SR<br>A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection. | Procedure: 3D model guided secondary resection<br>* A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function | IIEF-5 | 1 year | 
| Oncologic follow-up | PSA Monitoring | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostatectomy, nerve sparing, 3D model, urology, frozen section