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Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

RecruitingNAAges 18 Years - 70 YearsMaleEuropean Institute of Oncology
NCT06059859 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Augmented reality robot-assited radical prostatectomy
  • Mixed reality intraoperative frozen section analysis
  • Robot-assited radical prostatectomy
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Where

1 site
European Institute of Oncology
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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