Clinical trial NCT05960669: Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
Official title: Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostatectomy
nerve sparing
3D model
urology
frozen section
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Intuitive Surgical
First posted: 2023-07-27
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort Study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status
timeFrame: 4 weeks
Secondary outcomes:
measure: Erectile function
timeFrame: 1 year
measure: Oncologic follow-up
timeFrame: 1 year
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel Urologie
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christian CE Engesser, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Basel, Switzerland
name: Jan JE Ebbing, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: