Artificial intelligence 3D augmented reality robot-assisted radical prostatectomy versus no 3D intervention: a prospective multicenter randomized controlled trial

Istituti di Ricovero e Cura a Carattere Scientifico0 sites132 target enrollmentJanuary 30, 2023

Overview

No summary available.

Registry

who.int

Start Date

January 30, 2023

End Date

October 1, 2027

Last Updated

3 years ago

Study Type

Interventional

Sex

Male

Sponsor

Istituti di Ricovero e Cura a Carattere Scientifico

•1\. Signature of written informed consent and consent to use of personal data
•2\. Aged 40 years old and over and male
•3\. Preoperative MRI performed according to ESUR recommendations and reported in accordance with PiRads V.2
•4\. Disease with pre\-operative MRI finding of bulging or radiological T3
•5\. Histological diagnosis of acinar prostate carcinoma at the level of the area shown on MRI
•6\. Absence of retroperitoneal or pelvic bulky (\>3 cm) lymph node, bone or visceral metastatic lesions
•7\. Patients eligible for radical prostatectomy \+ pelvic lymphadenectomy
•8\. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0\-1
•9\. Life expectancy \=5 years
•10\. Patients motivated to preserve an erection and with pre\-operative sexual activity with IIEF \>17

•1\. Special histotypes of prostate cancer
•2\. Patients with PSA \>100 ng/ml at diagnosis
•3\. Unable to perform MRI (pacemaker wearers, claustrophobia) or MRI of inadequate quality to obtain 3D reconstruction
•4\. Concomitant treatment with other antineoplastic drugs including experimental endocrine therapies
•5\. Severe disease or concomitant uncontrolled medical condition including active and uncontrolled infections
•6\. Patients with dementia or psychiatric illness that would limit compliance with the requirements of the study or could prevent understanding and/or signing of informed consent