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

Not Applicable

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT05960669
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

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 Timeline

• Study Start: 2018-08-01
• Primary Completion: 2021-08-26
• Study Completion: 2022-08-26
• Status Verified: 2023-07
• Study First Submitted: 2023-07-17
• Study First Submitted QC: 2023-07-17
• Last Update Submitted: 2023-07-17
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Erectile function	1 year	IIEF-5
Oncologic follow-up	1 year	PSA Monitoring

Trial Locations

Locations (1)

Universitätsspital Basel Urologie; 🇨🇭 Basel, Switzerland