About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
Treatment groups
Sponsors and collaborators
Fondazione del Piemonte per l'Oncologia
Lead sponsor
San Luigi Gonzaga Hospital
Collaborator