Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

Trial Title: Artificial Intelligence 3D Augmented Reality Robot-Assisted-Radical- Prostatectomy v.s. no3D Intervention

NCT ID: NCT06318559

Condition: Cancer of Prostate

Conditions: Official terms:
Prostatic Neoplasms

Conditions: Keywords:
3D AI-AR-RARP
Cancer of Prostate
prostate surgery
Hyper-Accuracy 3D reconstruction (HA3DTM)
Riders
computer vision
Robot-assisted
laparoscopic radical prostatectomy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy
Description: The operation is performed using the "Da Vinci HD" robotic system which allows the use of laparoscopic instruments, with greater mobility and the possibility of easier and more precise control of movements in three dimensions. Furthermore, the system allows the surgeon a three-dimensional view of the operating field. The surgery is performed under general anesthesia. Six or more trocars are positioned, into which the instruments operated by the robot or directly by the surgical assistants are inserted. Then a radical prostatectomy is performed.
Arm group label: 3D group
Arm group label: no3D group

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).

Criteria for 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.

Gender: Male

Minimum age: 40 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Address:
City: Candiolo
Zip: 10060
Country: Italy

Status: Recruiting

Contact:
Last name: Enrico Checcucci, MD

Phone: +390119933632
Email: enrico.checcucci@ircc.it

Facility:
Name: AOU san Luigi Gonzaga

Address:
City: Orbassano
Zip: 10060
Country: Italy

Status: Recruiting

Contact:
Last name: Francesco Porpiglia, MD

Start date: June 29, 2022

Completion date: December 31, 2027

Lead sponsor:
Agency: Fondazione del Piemonte per l'Oncologia
Agency class: Other

Collaborator:
Agency: San Luigi Gonzaga Hospital
Agency class: Other

Source: Fondazione del Piemonte per l'Oncologia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06318559