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

Sponsor

University Hospital, Basel, Switzerland (Other)

Overall Status

Completed

CT.gov ID

NCT05960669

Collaborator

Intuitive Surgical (Industry)

100

Enrollment

Location

Arm

48.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Procedure: 3D model guided secondary resection	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Cohort StudyCohort Study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Aug 26, 2021

Actual Study Completion Date :

Aug 26, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3D model guided SR 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 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.

Arm

Intervention/Treatment

Experimental: 3D model guided SR

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

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.

Outcome Measures

Primary Outcome Measures

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

Erectile function [1 year]
IIEF-5
Oncologic follow-up [1 year]
PSA Monitoring

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsspital Basel Urologie	Basel		Switzerland	4031

Sponsors and Collaborators

University Hospital, Basel, Switzerland
Intuitive Surgical

Investigators

Principal Investigator: Christian CE Engesser, Dr., University Hospital, Basel, Switzerland
Principal Investigator: Jan JE Ebbing, PD Dr. med, University Hospital, Basel, Switzerland