Impact of Augmented Reality During Robot-assisted Radical Prostatectomy

Prostatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059859
• Other study ID #: IEO 1310
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: European Institute of Oncology
• Contact: Stefano Luzzago, MD
• Phone: +393335424928
• Email: stefano.luzzago[@]ieo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Procedure:
• 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.

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

Procedure:
• 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.

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive surgical margins	Pathological examination of positive surgical margins according to the criteria of the prostate consensus working group	Time zero
Secondary	Surgical time	Total operative time (mins) will we measured from skin incision to skin closure	Time zero
Secondary	Nerve-sparing approach	Rates of nerve-sparing approaches between groups will be evaluated according to the Tewari et al. scale	Time zero
Secondary	Erectile function	Erectile function recovery will be measured with the International Index of Erectile Function-5 questionnaire	3-6-12 months after surgery