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

NCT ID: NCT05982418

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-01-31

Brief Summary

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

3D patient-specific printed models are given to the surgeon before the start of RARP on a given patient. These 3D models are generated using automatic segmentation in MONAI followed by validation by a radiologist, and then post-processed for 3D printing.

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.

Group Type: EXPERIMENTAL

3D Virtual Models (Innersight Labs)

Intervention Type: DEVICE

3D patient-specific virtual models loaded into Innersight Labs platform are given to the surgeon before the start of RARP on a given patient. These 3D models are generated using automatic segmentation in MONAI followed by validation by a radiologist, and then post-processed for 3D visualisation.

Interventions

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

3D patient-specific printed models are given to the surgeon before the start of RARP on a given patient. These 3D models are generated using automatic segmentation in MONAI followed by validation by a radiologist, and then post-processed for 3D printing.

Intervention Type: DEVICE

3D Virtual Models (Innersight Labs)

3D patient-specific virtual models loaded into Innersight Labs platform are given to the surgeon before the start of RARP on a given patient. These 3D models are generated using automatic segmentation in MONAI followed by validation by a radiologist, and then post-processed for 3D visualisation.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Alejandro Granados, PhD

Role: CONTACT

alejandro.granados@kcl.ac.uk

07964840608

Other Identifiers

152847

Identifier Type: -

Identifier Source: org_study_id