Cancer of Prostate Clinical Trial
— RIDERSOfficial title:
RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled 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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 99 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo | Candiolo | Turin |
Italy | AOU san Luigi Gonzaga | Orbassano | Turin |
Lead Sponsor | Collaborator |
---|---|
Fondazione del Piemonte per l'Oncologia | San Luigi Gonzaga Hospital |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Verify the potential application of AI | Verify the potential application of AI as an alert system during surgery in order to reduce the rate of possible intraoperative complications | 12 months after surgery | |
Primary | Perioperative surgical oncological outcomes | Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery | 12 months after surgery | |
Secondary | Micturition outcomes | Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions. | 5 years after surgery | |
Secondary | Sexual function outcomes | Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire). | 5 years after surgery | |
Secondary | Oncological outcomes | Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication | 5 years after surgery |
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