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 个研究点目标入组 132 人开始时间: 2023年1月30日最近更新: 2023年2月13日

适应症

试验速览

暂无简介。

•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
•11. Availability of patient's pre-operative clinical data
•12. Patients must be available for protocol follow-up visits and consent to data collection

•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

发起方

Istituti di Ricovero e Cura a Carattere Scientifico