RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
Condition: Cancer of Prostate
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT06318559
Sponsor: Fondazione del Piemonte per l'Oncologia
Eligibility:
- Age: minimum 40 Years maximum 99 Years
- Gender: Male
Inclusion Criteria:
- 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
- Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
- Absence of bulky (>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
- Patients eligible for radical prostatectomy + pelvic lymphadenectomy
- ECOG PS 0-1
- Life expectancy ≥ 5 years
- Patients motivated to preserve erection and with pre-operative sexual activity with IIEF >17
- Availability of the patient's pre-operative clinical data
- Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection
Exclusion Criteria:
- 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
- Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
- Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.
View trial on ClinicalTrials.gov