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Clinical Trials in Italy / NCT06059859
Recruiting Not applicable

Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

NCT06059859 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Not applicable
Started
2022-01-01
Last updated
2025-08-12

Condition(s) studied

Prostatic Neoplasm

Investigational drug(s) / intervention(s)

Augmented reality robot-assited radical prostatectomyMixed reality intraoperative frozen section analysisRobot-assited radical prostatectomy

Augmented reality robot-assited radical prostatectomy: 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.

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

Robot-assited radical prostatectomy: 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.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: 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) Exclusion Criteria: 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

Primary outcome measure(s)

  • Positive surgical margins — Time zero
    Pathological examination of positive surgical margins according to the criteria of the prostate consensus working group

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06059859 on ClinicalTrials.gov ↗ ← All trials in Italy