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

NCT05982418 | Unknown DMC

• 1 other identifier: 152847
• Study Type: interventional
• Target: 162
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Urinary incontinence leak outcomes

  Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)

• Urinary incontinence pad weights outcomes

  Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)

• Urinary incontinence quality of life outcomes

  Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)

• Erectile dysfunction functional outcomes

  Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)

• Surgeon's perspectives

  Assessed only once after surgery and once surgeon has participated in both arms. Reported at end of study (6 months)

Study Arms (2)

3D Printed Models

EXPERIMENTAL

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 Virtual Models

EXPERIMENTAL

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)

Interventions

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

3D Virtual Models (Innersight Labs) 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.

3D Virtual Models

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• King's College London: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Alejandro Granados, PhD

CONTACT

07964840608; alejandro.granados@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A total of 108 patients will be recruited prospectively, i.e. 54 patients for intervention arm 1 (3D printed models), and 54 patients for intervention arm 2 (3D virtual models). An additional set of 54 patients will be obtained retrospectively.

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 8, 2023
• Study Start: July 31, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: August 8, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share