Comparing 3D AI-assisted prostate surgery to standard techniques

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective randomized multicenter study aims to evaluate the effectiveness of 3D artificial intelligence augmented reality robot-assisted radical prostatectomy (AI-AR-RARP) compared to traditional surgical methods. The study focuses on the ability of this advanced technology to improve oncological and functional outcomes by providing surgeons with enhanced spatial visualization of prostate cancer lesions during surgery. By potentially reducing positive surgical margins and preserving neurovascular bundles, the study seeks to improve postoperative recovery in terms of continence and potency, as well as decrease the risk of biochemical disease recurrence and metastasis.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Enrico Checcucci, MD — Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
• Study coordinator: Enrico Checcucci, MD
• Email: enrico.checcucci@ircc.it
• Phone: +390119933632

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.