Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

NCT06059859 | Recruiting

• 1 other identifier: IEO 1310
• Study Type: interventional
• Target: 318
• Locations: 1 country
• Sites: 1

Brief Summary

Accurate preservation of neuro-vascular bundles is crucial in guaranteeing erectile function recovery after robot assisted radical prostatectomy (RARP). However, the nerve sparing approach is associated with higher rates of positive surgical margins (PSM) at final pathology. Augmented reality (AR) RARP was previously associated with a 10-15% reduction in the rates of PSMs in two retrospective series. However, prospective studies are needed to demonstrate clinical utility and to validate these technologies. The hypotheses of this study are that: 1) AR RARP reduces the rates of PSMs, if compared to standard approach; 2) AR RARP can guarantee a more accurate preservation of neurovascular bundles and, in consequence, a greater recovery of erectile function; 3) the lower rates of PSMs will translate in greater oncological control of the disease.

Conditions

Prostatic Neoplasm

Outcome Measures

Primary Outcomes (1)

• Positive surgical margins

  Pathological examination of positive surgical margins according to the criteria of the prostate consensus working group

  Time zero

Secondary Outcomes (3)

• Surgical time

  Time zero

• Nerve-sparing approach

  Time zero

• Erectile function

  3-6-12 months after surgery

Study Arms (2)

Augmented reality robot-assited radical prostatectomy

EXPERIMENTAL

Robot-assisted radical prostatectomy using the Da Vinci surgical robot system (XI model; Intuitive Surgical, Sunnyvale, Calif) and a port device (Alexis; Applied Medical, Rancho Santa Margarita, Calif) system for prostate extraction. Virtual image of the prostate will be overlapped onto the endoscopic view of the Da Vinci surgical robot system using the TilePro system.

Procedure: Augmented reality robot-assited radical prostatectomy; Device: Mixed reality intraoperative frozen section analysis

Robot-assited radical prostatectomy

ACTIVE COMPARATOR

Robot-assisted radical prostatectomy using the Da Vinci surgical robot system (XI model; Intuitive Surgical, Sunnyvale, Calif) and a port device (Alexis; Applied Medical, Rancho Santa Margarita, Calif) system for prostate extraction

Procedure: Robot-assited radical prostatectomy

Interventions

Augmented reality robot-assited radical prostatectomy PROCEDURE

Robot assisted radical prostatectomy using the Da Vinci surgical robot system (XI model; Intuitive Surgical, Sunnyvale, Calif) and a port device (Alexis; Applied Medical, Rancho Santa Margarita, Calif) system for prostate extraction. Virtual image of the prostate will be overlapped onto the endoscopic view of the Da Vinci surgical robot system using the TilePro system.

Augmented reality robot-assited radical prostatectomy

Mixed reality intraoperative frozen section analysis DEVICE

Microsoft Hololens head-mounted display system will be used for inking prostate margins during intraoperative frozen section analysis

Augmented reality robot-assited radical prostatectomy

Robot-assited radical prostatectomy PROCEDURE

Robot assisted radical prostatectomy using the Da Vinci surgical robot system (XI model; Intuitive Surgical, Sunnyvale, Calif) and a port device (Alexis; Applied Medical, Rancho Santa Margarita, Calif) system for prostate extraction.

Robot-assited radical prostatectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Men with prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Untreated, biopsy-proven adenocarcinoma of the prostate Age ≥18 years
• European Association of Urology (EAU) low or intermediate risk prostate cancer:
• PSA≤20 ng/ml
• cT≤2b
• International Society for Urological Pathology \[ISUP\] grade group≤III Written informed consent provided for participation in the trial International Index of Erectile Function-5 (IIEF-5)≥20 No contraindications for multiparametric magnetic resonance imaging (mpMRI)

You may not qualify if:

• Any prior therapy for prostate cancer
• European Association of Urology (EAU) high risk prostate cancer:
• PSA\>20 ng/ml or
• cT\>2b or
• ISUP grade group\>III International Index of Erectile Function-5 (IIEF-5)\<20 Prostate cancer with sarcomatoid or spindle cell or neuroendocrine small cell components Morbidity that would limit compliance with study protocols Controindications to perform mpMRI

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, 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

• Ottavio de Cobelli, MD; PhD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Luzzago, MD

CONTACT

+393335424928; stefano.luzzago@ieo.it

Francesco A Mistretta, MD

CONTACT

+393405989010; francescoalessandro.mistretta@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

IT (1)