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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

3D model guided secondary resection

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring prostatectomy, nerve sparing, 3D model, urology, frozen section

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Universitätsspital Basel Urologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

3D model guided SR

Arm 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.

Outcomes

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

Secondary Outcome Measures

Erectile function

IIEF-5

Oncologic follow-up

PSA Monitoring

Full Information

NCT ID

NCT05960669

First Posted

July 17, 2023

Last Updated

July 17, 2023

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Intuitive Surgical

1. Study Identification

Unique Protocol Identification Number

NCT05960669

Brief Title

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

Acronym

AURORA

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

August 26, 2021 (Actual)

Study Completion Date

August 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

Collaborators

Intuitive Surgical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

prostatectomy, nerve sparing, 3D model, urology, frozen section

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Cohort Study

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

3D model guided SR

Arm Type

Experimental

Arm 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.

Intervention Type

Procedure

Intervention Name(s)

3D model guided secondary resection

Intervention Description

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.

Primary Outcome Measure Information:

Title

comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Erectile function

Description

IIEF-5

Time Frame

1 year

Title

Oncologic follow-up

Description

PSA Monitoring

Time Frame

1 year

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian CE Engesser, Dr.

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jan JE Ebbing, PD Dr. med

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsspital Basel Urologie

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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