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.
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
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
Parallel
3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
Procedure/SurgeryThe 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 inserted. Then a radical prostatectomy is performed.
Perioperative surgical oncological outcomes
Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery
Micturition outcomes
Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions.
Sexual function outcomes
Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire).
Oncological outcomes
Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication
Verify the potential application of AI
Verify the potential application of AI as an alert system during surgery in order to reduce the rate of possible intraoperative complications
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Fondazione del Piemonte per l'Oncologia
Lead sponsor
San Luigi Gonzaga Hospital
Collaborator
