Augmented Reality Guidance During Robot-Assisted Prostate Removal Surgery

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for men who have not yet been treated for low or intermediate risk prostate cancer and who still have good erectile function. It tests augmented reality during robot-assisted prostate removal surgery.

Age

From 18 to 70 years.

Sex

Men only.

Disease stage

Biopsy-proven adenocarcinoma of the prostate, EAU low or intermediate risk: PSA 20 ng/ml or less, cT 2b or less, ISUP grade group III or less.

Earlier treatment

No prior treatment for prostate cancer.

Biomarker or test result

IIEF-5 score of 20 or more (erectile function questionnaire).

Main reasons for not taking part

• Any prior therapy for prostate cancer
• EAU high risk prostate cancer: PSA above 20 ng/ml, cT above 2b, or ISUP grade group above III
• IIEF-5 score below 20
• Sarcomatoid, spindle cell or neuroendocrine small cell components
• Illness that would limit following the study protocol, or no possibility to have a multiparametric MRI

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 70 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• Augmented reality robot-assited radical prostatectomyTreatment being tested

  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.

  Treatment: Augmented reality robot-assited radical prostatectomy and Mixed reality intraoperative frozen section analysis

• Robot-assited radical prostatectomyExisting treatment, for comparison

  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