Health TrialsbyHealthPanel

Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

ConditionProstatic Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-70
SponsorEuropean Institute of Oncology

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Augmented reality robot-assited radical prostatectomy

    Procedure/Surgery

    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

    Device

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

  • Robot-assited radical prostatectomy

    Procedure/Surgery

    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.

Treatment groups

318 Participants
are divided into 2 treatment groups
Group A: Augmented reality robot-assited radical prostatectomyExperimental treatment 2 interventions
Group B: Robot-assited radical prostatectomyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Positive surgical margins

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

Time frame
Time zero

Secondary outcomes

1

Surgical time

Total operative time (mins) will we measured from skin incision to skin closure

Time frame
Time zero
2

Nerve-sparing approach

Rates of nerve-sparing approaches between groups will be evaluated according to the Tewari et al. scale

Time frame
Time zero
3

Erectile function

Erectile function recovery will be measured with the International Index of Erectile Function-5 questionnaire

Time frame
3-6-12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Institute of Oncology

Lead sponsor

Source ClinicalTrials.gov
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