Clinical trial NCT05982418: Improvement of RARP Outcomes Via 3D Printed/Virtual Prostate Models
Official title: Improvement of Robotic-assisted Radical Prostatectomy (RARP) Outcomes Via Automatedly Segmented 3D Printed and Virtual Prostate Models: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: King's College London
First posted: 2023-08-08
Enrollment: 162
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Automated segmentation metrics
timeFrame: Assessed after mp-MRI of patient is available and before surgery (RARP). Reported at end of study (6 months).
measure: Patient recruitment rate
timeFrame: Assessed throughout the study for each patient. Reported at end of study (6 months).
measure: Percentage of cases that led to successful model deployment to the theatre
timeFrame: Assessed throughout the study for each patient. Reported at end of study (6 months).
measure: Positive resection margins
timeFrame: Duration of the study
Secondary outcomes:
measure: Urinary incontinence leak outcomes
timeFrame: Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
measure: Urinary incontinence pad weights outcomes
timeFrame: Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
measure: Urinary incontinence quality of life outcomes
timeFrame: Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
measure: Erectile dysfunction functional outcomes
timeFrame: Assessed at 6 weeks and 3 months after surgery. Reported at end of study (6 months)
measure: Surgeon's perspectives
timeFrame: Assessed only once after surgery and once surgeon has participated in both arms. Reported at end of study (6 months)
measure: Patient's perspectives
timeFrame: Assessed after surgery and after first clinical follow-up at 6 weeks. Reported at end of study (6 months).
measure: Accuracy metrics for the automated segmentation of other structures
timeFrame: Assessed after mp-MRI of patient is available and before surgery (RARP). Reported at end of study (6 months).
measure: Surgical phase and action recognition
timeFrame: Assessed and reported at end of study (6 months).
Other outcomes:
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