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

NCT06318559 | Recruiting

• 1 other identifier: 027-FPO22
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Perioperative surgical oncological outcomes

  Verify oncological outcomes in prostate cancer patients with evidence of bulging or extracapsular disease (ECE or rT3) on preoperative MRI, in terms of positive margin rate (PSM) following surgery

  12 months after surgery

Secondary Outcomes (3)

• Micturition outcomes

  5 years after surgery

• Sexual function outcomes

  5 years after surgery

• Oncological outcomes

  5 years after surgery

Other Outcomes (1)

• Verify the potential application of AI

  12 months after surgery

Study Arms (2)

3D group

EXPERIMENTAL

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

Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

no3D group

ACTIVE COMPARATOR

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.

Procedure: 3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy

Interventions

3D Robot-assisted laparoscopic radical prostatectomy and pelvic lymphadenectomy 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.

3D group; no3D group

Eligibility Criteria

• Age: 40 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signature of the written informed consent and consent to the use of personal data
• Age \> 40 years and male sex
• Pre-operative MRI performed according to ESUR recommendations and reporting in accordance with PiRads V.2
• Disease with evidence of bulging or radiological T3 on pre-operative MRI
• Histological diagnosis of acinar type prostate cancer in the area highlighted on MRI
• Absence of bulky (\>3 cm), bony or visceral retroperitoneal or pelvic lymph node metastatic lesions
• Patients eligible for radical prostatectomy + pelvic lymphadenectomy
• ECOG PS 0-1
• Life expectancy ≥ 5 years
• Patients motivated to preserve erection and with pre-operative sexual activity with IIEF \>17
• Availability of the patient's pre-operative clinical data
• Patients must be available to carry out the visits foreseen in the follow-up of the protocol and consent to data collection

You may not qualify if:

• Special histotypes of prostate cancer
• Patients with PSA \> 100 ng/ml at diagnosis
• Inability to perform MRI (pacemaker wearers, claustrophobia...) or MRI of inadequate quality to obtain the HA3DTM 3D reconstruction
• Concomitant treatment with other antineoplastic drugs including investigational endocrine therapies
• Serious uncontrolled concomitant medical condition or disease including active, uncontrolled infections
• Patients with dementia or psychiatric illness that limit compliance with study requirements or that may prevent understanding and/or signing informed consent.

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead
• San Luigi Gonzaga Hospital: collaborator

Study Sites (2)

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin, 10060, Italy

RECRUITING

AOU san Luigi Gonzaga

Orbassano, Turin, 10060, Italy

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Enrico Checcucci, MD

  Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Enrico Checcucci, MD

CONTACT

+390119933632; enrico.checcucci@ircc.it

Marco Asioli

CONTACT

+390119933463; marco.asioli@ircc.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 19, 2024
• Study Start: June 29, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

IT (2)