Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

Official title

RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial

Overview

This is a prospective randomized multicenter study aimed at comparing 3D AI-AR-RARP vs. no 3D, verifying the impact of this new technology on oncological and functional outcomes after the procedure.

Detailed description

Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).

Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).

Interventions

• Procedure 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
  The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are in

Primary outcome measures

• Perioperative surgical oncological outcomes [Time frame: 12 months after surgery]

Secondary outcome measures (3)

• Micturition outcomes [Time frame: 5 years after surgery]
• Sexual function outcomes [Time frame: 5 years after surgery]
• Oncological outcomes [Time frame: 5 years after surgery]

Eligibility criteria

Inclusion criteria

• Signature of the written informed consent and consent to the use of personal data
• Age > 40 years and male sex
• Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
• Disease with evidence of bulging or radiological T3 on pre-operative MRI
• Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
• Absence of bulky (>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
• Patients eligible for radical prostatectomy + pelvic lymphadenectomy
• ECOG PS 0-1
• Life expectancy ≥ 5 years
• Patients motivated to preserve erection and with pre-operative sexual activity with IIEF >17
• Availability of the patient's pre-operative clinical data
• Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection

Exclusion criteria

• Special histotypes of prostate cancer
• Patients with PSA > 100 ng/ml at diagnosis
• Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
• Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
• Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
• Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Italy · 2 centers

• Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo — Candiolo
• AOU san Luigi Gonzaga — Orbassano

Identifiers

NCT: NCT06318559 · 027-FPO22

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗