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

University Hospital Basel

Status: Completed

Conditions: Prostate Cancer

Treatments: Procedure: 3D model guided secondary resection

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05960669

AURORA_2018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

3D model guided SR

Experimental group

Description:

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.

Treatment:

Procedure: 3D model guided secondary resection