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

Prostate Cancer Clinical Trial

— RARP-3D  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05982418
• Other study ID #: 152847
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 31, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: December 2022
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Alejandro Granados, PhD
• Phone: 07964840608
• Email: alejandro.granados[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 162
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	Positive resection margins	Assessed after surgery and after specimen analysis. Reported at end of study (6 months).	Duration of the study
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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).
Secondary	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).
Secondary	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).