Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

Официальное название

A Phase III Prospective Randomized Trial to Evaluate the Impact of Augmented Reality During Robot-assisted Radical Prostatectomy on the Rates of Postoperative Surgical Margins

Обзор

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.

Подробное описание

This is a Phase III, monocentric, prospective trial in which patients will be randomized to AR RARP vs. standard approach (standard RARP). Patient population is defined as: patients≥18 years old, untreated biopsy-proven adenocarcinoma of the prostate classified as European Association of Urology (EAU) low or intermediate risk (PSA≤20 ng/ml and cT≤2b and International Society for Urological Pathology \[ISUP\] grade group≤III), pre-operative International Index of Erectile Function-5 (IIEF-5)≥20, no contraindications for multiparametric magnetic resonance imaging (mpMRI). The primary objective of this study is to compare the rates of PSMs with AR RARP vs. standard RARP. Secondary objectives are the rates of nerve sparing approaches and erectile function recovery at 3-, 6- and 12-months after surgery in AR RARP vs. standard RARP. Subgroup analyses will tested for a specific subgroup of patients in which AR RARP should be particularly indicated. Longer-term follow-up will also assess the percentages of biochemical recurrences (BCR) in the two groups.

Вмешательства

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

Первичные конечные точки

• Positive surgical margins [Срок оценки: Time zero]

Вторичные конечные точки (3)

• Surgical time [Срок оценки: Time zero]
• Nerve-sparing approach [Срок оценки: Time zero]
• Erectile function [Срок оценки: 3-6-12 months after surgery]

Критерии участия

Критерии включения

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)

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• European Institute of Oncology — Milan

Идентификаторы

NCT: NCT06059859 · IEO 1310

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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