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Recruiting NCT06318559

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

Trial Parameters

Condition Cancer of Prostate
Sponsor Fondazione del Piemonte per l'Oncologia
Study Type INTERVENTIONAL
Phase N/A
Enrollment 120
Sex MALE
Min Age 40 Years
Max Age 99 Years
Start Date 2022-06-29
Completion 2025-12-31
Interventions
3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Brief 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 Criteria

Inclusion Criteria: 1. Signature of the written informed consent and consent to the use of personal data 2. Age \> 40 years and male sex 3. Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2 4. Disease with evidence of bulging or radiological T3 on pre-operative MRI 5. Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI 6. Absence of bulky (\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions 7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy 8. ECOG PS 0-1 9. Life expectancy ≥ 5 years 10. Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \>17 11. Availability of the patient's pre-operative clinical data 12. Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection Exclusion Criteria: 1. Special histotypes of prostate cancer 2. Patients with PSA \

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