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

Improvement of Robotic-assisted Radical Prostatectomy (RARP) Outcomes Via Automatedly Segmented 3D Printed and Virtual Prostate Models: a Feasibility Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: 3D Printed Models (3D printing facilities at GSTT); Device: 3D Virtual Models (Innersight Labs)

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.

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alejandro Granados, PhD; Phone Number: 07964840608; Email: alejandro.granados@kcl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Automated segmentation metrics	Automated segmentation metrics in relation to the accuracy of predicted masks of prostate gland and lesions	Assessed after mp-MRI of patient is available and before surgery (RARP). Reported at end of study (6 months).
Patient recruitment rate	Patient recruitment rate will be captured throughout the study to measure effectiveness in preparation for a follow-up randomised control trial.	Assessed throughout the study for each patient. Reported at end of study (6 months).
Percentage of cases that led to successful model deployment to the theatre	Percentage of cases that led to successful model deployment to the theatre will be captured throughout the study to measure effectiveness in preparation for a follow-up randomised control trial.	Assessed throughout the study for each patient. Reported at end of study (6 months).
Positive resection margins	Assessed after surgery and after specimen analysis. Reported at end of study (6 months).	Duration of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence leak outcomes	These are captured via questionnaires (ICIQ-UI) answered by patients in relation to urinary leaks.	Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
Urinary incontinence pad weights outcomes	These are captured via questionnaires (EPROM) answered by patients in relation to urinary incontinence measured by pad weights.	Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
Urinary incontinence quality of life outcomes	These are captured via questionnaires (ICIQ-LUTS-QoL) answered by patients in relation to quality of life resulting from urinary incontinence.	Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
Erectile dysfunction functional outcomes	These are captured via questionnaires (IIEF, and erectile hardness score) answered by patients in relation to erectile dysfunction.	Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
Surgeon's perspectives	Surgeon's perspectives on the use of patient-specific 3D printed and virtual prostate models during surgery will be captured after surgery	Assessed only once after surgery and once surgeon has participated in both arms. Reported at end of study (6 months)
Patient's perspectives	Patient's perspectives on the use of their patient-specific 3D printed and virtual prostate model after surgery will be captured after surgery during clinic review	Assessed after surgery and after first clinical follow-up at 6 weeks. Reported at end of study (6 months).
Accuracy metrics for the automated segmentation of other structures	Accuracy metrics of a model that will automatically identify neurovascular bundles, urethra, and external sphincter based on manually identified masks on mp-MRI	Assessed after mp-MRI of patient is available and before surgery (RARP). Reported at end of study (6 months).
Surgical phase and action recognition	Surgical phase and action recognition accuracy metrics of RARP endoscopic videos to understand the actions done leading to the reported complications	Assessed and reported at end of study (6 months).

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Estimated): July 31, 2023
• Primary Completion (Estimated): January 31, 2024
• Study Completion (Estimated): January 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: 152847

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No