RecruitingNot ApplicableNCT06318559

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

Sponsor

Fondazione del Piemonte per l'Oncologia

Enrollment

120 participants

Start Date

Jun 29, 2022

Study Type

INTERVENTIONAL

Conditions

Cancer of Prostate

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

Sex: MALEMin Age: 40 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study compares two approaches to robot-assisted prostate removal surgery — one using 3D augmented reality and artificial intelligence guidance versus standard robotic surgery without 3D visualization — to see if the new technology improves outcomes like nerve preservation and cancer control. **You may be eligible if...** - You are a male patient over 40 years old - You have been diagnosed with prostate cancer confirmed by biopsy in an area identified on MRI - Your cancer shows signs of being at an intermediate or locally advanced stage (T3 on imaging) - You are a candidate for radical prostatectomy (surgical removal of the prostate) with pelvic lymph node removal - You are motivated to preserve sexual function and have pre-surgical erectile function - Your general health is good (ECOG 0-1) **You may NOT be eligible if...** - You have bulky or distant metastatic disease - You are not a candidate for surgery - You have a life expectancy of less than 5 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURE3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

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.