Clinical trial NCT06318559: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention
Official title: RIDERS: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention: a Prospective Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer of Prostate
Keywords: 3D AI-AR-RARP
Cancer of Prostate
prostate surgery
Hyper-Accuracy 3D reconstruction (HA3DTM)
Riders
computer vision
Robot-assisted
laparoscopic radical prostatectomy
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
Collaborators: name: San Luigi Gonzaga Hospital
First posted: 2024-03-19
Enrollment: 120
Sex: MALE
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized using an Excel® macro in 2 group: 3D and no3D, stratifying them by age, PSA, cT, PSA density, prostate volume, lesion volume, extracapsular extension (ECE), seminal vesicle invasion (SVI), biopsy ISUP.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Considering that prostate cancer lesions are not identifiable during surgery, except in the case of extensive and advanced tumors, the surgeon does not have a real-time perception of the location of the tumor. The absence of clear spatial visualization can therefore lead to a positive surgical margin, particularly in tumors in the T3 stage (invasion of the prostatic capsule or seminal vesicles).

Our hypothesis is that with the help of AI 3D AR during surgery, positive surgical margins can be avoided, or at least reduced, while preserving the neurovascular bundles, with a consequent improvement not only in postoperative functional outcomes (continence and potency), but also oncological ones (less biochemical disease recovery (BCR), less need for salvage radiotherapy, lower risk of metastasis).

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.

Primary outcomes:
measure: Perioperative surgical oncological outcomes
timeFrame: 12 months after surgery
Secondary outcomes:
measure: Micturition outcomes
timeFrame: 5 years after surgery
measure: Sexual function outcomes
timeFrame: 5 years after surgery
measure: Oncological outcomes
timeFrame: 5 years after surgery
Other outcomes:
measure: Verify the potential application of AI
timeFrame: 12 months after surgery
Locations:
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
state: Turin
city: Orbassano
country: Italy
facility: AOU san Luigi Gonzaga
state: Turin
Study officials:
affiliation: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
name: Enrico Checcucci, MD
role: PRINCIPAL_INVESTIGATOR
References: