Prostate cancer Cancer
Conditions
Interventions
Patients with localized prostate cancer suitable for robot-assisted radical prostatectomy will be randomized into two groups:
Group 1: Artificial intelligence 3D augmented reality robo
while contralaterally an intra-, inter- or extra-fascial NS technique will be performed depending on the clinical indication. At the end of the demolition phase, following the removal of the prostate
Sponsors
Istituti di Ricovero e Cura a Carattere Scientifico
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signature of written informed consent and consent to use of personal data 2. Aged 40 years old and over and male 3. Preoperative MRI performed according to ESUR recommendations and reported in accordance with PiRads V.2 4. Disease with pre-operative MRI finding of bulging or radiological T3 5. Histological diagnosis of acinar prostate carcinoma at the level of the area shown on MRI 6. Absence of retroperitoneal or pelvic bulky (>3 cm) lymph node, bone or visceral metastatic lesions 7. Patients eligible for radical prostatectomy + pelvic lymphadenectomy 8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1 9. Life expectancy =5 years 10. Patients motivated to preserve an erection and with pre-operative sexual activity with IIEF >17 11. Availability of patient's pre-operative clinical data 12. Patients must be available for protocol follow-up visits and consent to data collection
Exclusion criteria
Exclusion criteria: 1. Special histotypes of prostate cancer 2. Patients with PSA >100 ng/ml at diagnosis 3. Unable to perform MRI (pacemaker wearers, claustrophobia) or MRI of inadequate quality to obtain 3D reconstruction 4. Concomitant treatment with other antineoplastic drugs including experimental endocrine therapies 5. Severe disease or concomitant uncontrolled medical condition including active and uncontrolled infections 6. Patients with dementia or psychiatric illness that would limit compliance with the requirements of the study or could prevent understanding and/or signing of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive surgical margins rate measured using whole amount histopathological exam of sections 1 to 30 days postoperatively | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Sexual function measured using the International Index of Erectile Function 5 Questionnaire at 1, 3, 6, 12, 18 and 24 months after surgery 2. Urinary continence measured by weighing protective pads before and after use to quantify the amount of urine leaked into the pad at 1, 3, 6, 12, 18 and 24 months after surgery 3. Prostate-specific antigen (PSA) levels in serum measured using a serum PSA ELISA test at 1, 3, 6, 12, 18 and 24 months after surgery | — |
Countries
Italy
Outcome results
None listed