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

Not Applicable

Recruiting

• Conditions: Cancer of Prostate

• Registration Number: NCT06318559
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

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).

Study Timeline

• Study Start: 2022-06-29
• Study First Submitted: 2024-02-15
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-19
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perioperative surgical oncological outcomes	12 months after surgery	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

Secondary Outcome Measures

Name	Time	Method
Micturition outcomes	5 years after surgery	Evaluation of continence recovery rate. Continence was defined as use of 0-1 pads/die. Furthermore 24/h pad test was performed in case of persistence of incontinence to evaluate the different degree of urine losses, and was classified according to ICS definitions.
Sexual function outcomes	5 years after surgery	Evaluation of erection recovery in terms of IIEF-5 (International Index of Erectile Function Questionnaire).
Oncological outcomes	5 years after surgery	Evaluation of patients' oncological outcomes during the follow up in terms of biochemical recurrence (BCR) and occurrence of local/distant recurrence detected with different imaging techniques during the FU according to clinical indication

Trial Locations

Locations (2)

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo; 🇮🇹 Candiolo, Turin, Italy

AOU san Luigi Gonzaga; 🇮🇹 Orbassano, Turin, Italy