Improvement of RARP Outcomes via 3D Printed/Virtual Prostate Models
Research type
Research Study
Full title
Improvement of Robotic-assisted Radical Prostatectomy Outcomes via Automatedly Segmented 3D Printed and Virtual Prostate Models: a Feasibility Study
IRAS ID
312298
Contact name
Alejandro Granados
Contact email
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
In the current clinical pipeline for treating prostate cancer, men have medical images taken of their pelvic region to decide whether the patient is candidate for prostate removal before cancer further spreads into other surrounding anatomical structures. Surgeons decide where to cut the anatomy for removing the prostate based on the video feed shown through the camera and the knowledge of the prostate anatomy they acquire by observing medical images. The amount of tissue to remove is a trade-off between removing as much cancer as possible while preserving functional surrounding anatomical structures. The most common complications include positive surgical margins (i.e. a measure of how much cancer was left behind), urinary incontinence, and erectile dysfunction.
However, in preparation of a randomised control trial, we need answers to three key questions. First, how accurate could an automated tool for delineating prostate anatomy be and what are the benefits it has for the deployment of a study of a larger scale? Second, what is the effect of automatedly delineated 3D printed/virtual models available to the surgeon on the reduction of surgical outcomes?
To achieve this, we propose a feasibility study with the primary outcomes to measure patient outcomes, patient recruitment rate, and percentage of cases that led to successful model deployment to the theatre. We propose three investigation arms as follow: i) a retrospective control cohort of 54 patients that we use to compute a baseline of surgical outcomes, ii) a prospective group of 54 patients whereby 3D printed prostates are manipulated by surgeons during surgery, and iii) a prospective group of 54 patients whereby 3D virtual prostates are manipulated by surgeons during surgery.
Subjects are allocated in bulk to virtual arm followed by printed arm; all are T2b-T3 prostate cancer patients with Gleason’s score>=3+4 eligible for RARP at Guy’s Hospital.
REC name
London - Surrey Research Ethics Committee
REC reference
23/LO/0492
Date of REC Opinion
29 Jun 2023
REC opinion
Further Information Favourable Opinion