Comparing 3D AI-assisted prostate surgery to standard techniques

RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial

This study is testing whether a new 3D robot-assisted prostate surgery can help men with prostate cancer recover better and have fewer complications compared to standard surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 40 Years to 99 Years
• Sex: Male
• Sponsor: Fondazione del Piemonte per l'Oncologia (other)
• Locations: 2 sites (Candiolo, Turin and 1 other locations)
• Trial ID: NCT06318559 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are males over 40 years old with T3 stage prostate cancer who are eligible for radical prostatectomy and motivated to preserve erectile function.

Not a fit: Patients with special histotypes of prostate cancer or those with significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to better surgical outcomes and improved quality of life for prostate cancer patients.

How similar studies have performed: Other studies have shown promise in using advanced imaging technologies in surgical procedures, suggesting potential success for this novel approach.

Eligibility criteria

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 this trial is running

Candiolo, Turin and 1 other locations

• 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

Conditions: Cancer of Prostate, 3D AI-AR-RARP, prostate surgery, Hyper-Accuracy 3D reconstruction, Riders, computer vision, Robot-assisted, laparoscopic radical prostatectomy