Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

European Institute of Oncology

Status: Enrolling

Conditions: Prostatic Neoplasm

Treatments: Procedure: Robot-assited radical prostatectomy; Procedure: Augmented reality robot-assited radical prostatectomy; Device: Mixed reality intraoperative frozen section analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06059859

IEO 1310

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 318 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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318 participants in 2 patient groups

Augmented reality robot-assited radical prostatectomy

Experimental group

Description:

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:

Device: Mixed reality intraoperative frozen section analysis

Procedure: Augmented reality robot-assited radical prostatectomy

Robot-assited radical prostatectomy

Active Comparator group

Description:

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:

Procedure: Robot-assited radical prostatectomy