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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age40-99
SponsorFondazione del Piemonte per l'Oncologia

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

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Fondazione del Piemonte per l'Oncologia

Lead sponsor

San Luigi Gonzaga Hospital

Collaborator