Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
Fondazione del Piemonte per l'Oncologia
120 participants
Jun 29, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria12
- 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 Criteria6
- 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.
Interventions
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 inserted. Then a radical prostatectomy is performed.
Locations(2)
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NCT06318559