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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signature of the written willing to sign a consent form 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 Who Should NOT Join This Trial: 1. Special histotypes of prostate cancer 2. Patients with PSA \> 100 ng/ml at diagnosis 3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction 4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies 5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections 6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 \> 100 ng/ml at diagnosis 3. Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction 4. Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies 5. Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections 6. Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.

Treatments Being Tested

PROCEDURE

3D 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.

Locations (2)

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
Candiolo, Turin, Italy
AOU san Luigi Gonzaga
Orbassano, Turin, Italy