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

NCT ID: NCT06318559

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-29
• Study Completion Date: 2027-12-31

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).

Conditions

Cancer of Prostate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

3D group

in Group 3D, an intrafascial nerve-sparing (NS) technique will be performed on the side of the lesion; contralaterally an intra-, inter- or extra-fascial NS technique will be performed. After removal of the prostate, virtual images of the prostate will be projected into the lodge using AI software and will be displayed thanks to the Tile-Pro. The virtual 3D model will allow identifying the extracapsular extension of the tumor lesion, projected at the level of the preserved neurovascular bundle.

A first selective excisional biopsy at the level of the suspected ECE on the NVB will be sent for extemporaneous histological examination. Under 3D AR guidance, a second selective biopsy will then be performed on the NVB at the same level as the first, however involving a larger and thicker layer of tissue. the biopsies will be sent for extemporaneous histological examination. In case of positivity, the entire NVB will be removed

Group Type: EXPERIMENTAL

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Intervention Type: PROCEDURE

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.

no3D group

For the no-3D group, the intra-, inter- or extra-fascial NS technique during robotic prostatectomy will be performed according to the clinical indication.

At the end of the demolitive phase a selective biopsu was performed in a cognitive fashion accordin with the information provided by MRI images.

Reconstructive phase was performed according to our previously described total anatomical reconstruction (TAR) technique for both arms.

Group Type: ACTIVE_COMPARATOR

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Intervention Type: PROCEDURE

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.

Interventions

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

San Luigi Gonzaga Hospital

OTHER

Sponsor Role: collaborator

Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enrico Checcucci, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Locations

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, Italy

Site Status: RECRUITING

AOU san Luigi Gonzaga

Orbassano, Turin, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Enrico Checcucci, MD

Role: CONTACT

enrico.checcucci@ircc.it

+390119933632

Marco Asioli

Role: CONTACT

marco.asioli@ircc.it

+390119933463

Facility Contacts

Enrico Checcucci, MD

Role: primary

enrico.checcucci@ircc.it

+390119933632

Francesco Porpiglia, MD

Role: primary

Other Identifiers

027-FPO22

Identifier Type: -

Identifier Source: org_study_id