Improvement of RARP Outcomes Via 3D Printed/Virtual Prostate Models (RARP-3D)

Guy's and St Thomas' NHS Foundation Trust

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Device: 3D Printed Models (3D printing facilities at GSTT); Device: 3D Virtual Models (Innersight Labs)

Study type: Interventional

Funder types: Other

Identifiers

NCT05982418

152847

Details and patient eligibility

About

Study the effect 3D printed or 3D virtual prostate models of a patient, when manipulated by surgeons during RARP, has on positive surgical margins and functional outcomes of patients. Our main hypothesis is that there is a reduction of positive resection margins and functional outcomes of patients undergoing RARP when surgeons are presented with 3D printed or 3D virtual patient-specific prostate models during surgery. Specifically, we hypothesize that the anatomical knowledge of surgeons that results from the manipulation of 3D printed/virtual models constructed from automated segmentations reduces positive resection margins and functional outcomes.

Full description

This is a parallel group research feasibility study consisting of two intervention arms (3D printed and 3D virtual models) and a control group (standard practice). Intervention groups are prospective; control group is retrospective. Prospective patients, complying with the inclusion criteria, will randomly be allocated to only one intervention group.

Primary outcomes Study the effect of two-intervention arms (3D printed and virtual prostate models) have on the improvement of positive resection margins after RARP, validate the accuracy of automated methods when identifying masks of the prostate gland and, cancer lesions urethra, neurovascular bundles, and external sphincter, and validate the effectiveness of an automated deployment pipeline with the goal of setting groundwork in preparation for a randomise control trial in a subsequent study.

Secondary outcomes Study the effect of two-intervention arms have on functional outcomes, surgeons' and patients' perspectives on using 3D prostate models.

A total of 162 cases will be considered in this feasibility study stratified into 3 cohorts:

• Control group. The control group will consist of 54 retrospective case-matched dataset whereby mp-MRI, positive resection margins, and functional outcomes will be collected and used as a baseline. Automated segmentation of prostate gland and lesions will be done on mp-MRI.
• Intervention arm 1 - 3D printed models. This cohort will consist of 54 prospective cases whereby patient-specific 3D printed models will be available to the surgeon during RARP for manipulation.
• Intervention arm 2 - 3D virtual models. This cohort will consist of 54 prospective cases whereby 3D virtual models will be available to the surgeon during RARP for manipulation using Innersight Labs platform.

Enrollment: 162 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Eligible for RARP after assessment of mp-MRI during multi-disciplinary team meetings at Guy's Hospital
• T2b-T3 prostate cancer patients
• Gleason's score>=3+4 .

Exclusion criteria

• prior treatment for prostate cancer
• patients with pre-existing urinary incontinence problems
• patients where mp-MRI scans are not possible
• patients participating in other studies investigating functional outcomes after surgery will be excluded. This is to avoid other studies influencing our secondary endpoints.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

162 participants in 2 patient groups

3D Printed Models

Experimental group

Description:

This cohort will consist of 54 prospective cases whereby patient-specific 3D printed models will be available to the surgeon during RARP for manipulation.

Treatment:

Device: 3D Printed Models (3D printing facilities at GSTT)

3D Virtual Models

Experimental group

Description:

This cohort will consist of 54 prospective cases whereby 3D virtual models will be available to the surgeon during RARP for manipulation using Innersight Labs platform.

Treatment:

Device: 3D Virtual Models (Innersight Labs)