Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery (PERSEE II)

Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate

This multicenter study aimed at assessing the feasibility of Probe-based Confocal Laser Endomicroscopy (pCLE) during Robotic-Assisted Radical Prostatectomy or Laparoscopic Radical Prostatectomy for intra-operative characterisation of surgical margins.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: Confocal Laser Endomicroscopy

Detailed Description

Prostate cancer is one of the most diagnosed cancer in men. Several treatments are available depending on patient's clinical features. When the cancer is localised or locally advanced, one of the possible treatment is Radical Prostatectomy. A risk of that procedure is the incomplete removal of cancer tissues due to the presence of cancer cells within the resection margin. A histological analysis of the resected prostate allows to assess surgical margins. If cancer cells comes out to the edges of the removed tissue, it is called Positive Surgical Margin (PSM). Several studies showed that PSMs are more frequent in case of extra-prostatic extensions of the cancer and are correlated with biochemical recurrence.

A study conducted on 21 patients scheduled for Robotic-Assisted Radical Prostatectomy has already demonstrated the feasibility of the intra-operative observation of microscopic features of prostatic and periprostatic tissues in vivo and ex vivo with the Cellvizio® 100 Series system combined with the CelioFlex™ probe.

The main objective of the study is to assess the feasibility and safety of pCLE technology during radical prostatectomy (RP) and to assess the diagnostic performance of pCLE technology for the definition of the resection margins.

This method could be used to guide surgeons during nerve sparing surgery and provide real-time feedback for adequate dissection of NVB. As well, ex vivo characterisation of benign and cancerous glandular structures could provide an efficient and rapid method for intra-operative surgical margin assessment

The study is divided in 2 parts:

1. Ex vivo study

   An ex vivo study will be carried out on 15 firsts prostate specimens for pathologist training and generation of ex vivo pCLE images atlas.

2. In vivo study

Prior to pCLE analysis, a contrast agent (Fluorescein) will be administered:

• by intravenous injection in each prostatic pedicles before their ligation
• topically, after NVB dissection, in a spray solution through a catheter inserted in an assistant trocar or with a soaked gauze.

The Cellvizio will be used during the NVB dissection to acquire in vivo images and sequences of prostatic tissues.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Eric Barret, MD; Phone Number: 01 56 61 62 63; Email: eric.barret@imm.fr
    • Principal Investigator: Eric Barret, MD
  • Paris, France, 75012
    • Not yet recruiting
    • Groupe Hospitalier Diaconesses Croix Saint-Simon
    • Contact: Alexandre Colau, MD
    • Principal Investigator: Alexandre Colau, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Over 18 years
• Localised or locally advanced prostate cancer
• Agreement given for Radical Prostatectomy
• Not eligible or refusing an active surveillance protocol
• having given its signed informed consent

Exclusion Criteria:

• Under 18 years
• Previously treated for PCa (hormones, EBRT, focal treatments)
• Surgical history of BPH treatment
• Known allergy to Fluorescein

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Confocal Laser Endomicroscopy; All included patients will undergo probe-based Confocal Laser Endomicroscopy during Robotic-Assisted Radical Prostatectomy (RARP) or Laparoscopic Radical Prostatectomy (LRP)

Device: Confocal Laser Endomicroscopy; The study is divided in 2 parts.; Ex vivo studyProstate specimens will be stained using FluoresceinImages/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired.; In vivo studyIntravenous injection of contrast agentpCLE imaging every 5mm of the NVB dissection zone.; Other Names: pCLE; probe-based Confocal Laser Endomicroscopy; CelioFlex probe; Cellvizio 100 series

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pCLE criteria	Definition of pCLE criteria for normal and abnormal prostate tissues	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of use of the endomicroscopy device	The ease of use of the endomicroscopy device will be assessed using a questionnaire that the surgeon will fill at the end of each procedure	1 year
Audio/video telecommunication quality	The telecommunication quality will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure	1 year
Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0	The device safety will measure by assessing the occurence and severity of adverse events during the study	1 year
Stability and reproducibility of images/sequences during procedures	The stability and reproducibility of endomicroscopy images will be assessed using a questionnaire that the surgeon and the anatomopathologist will fill at the end of each procedure	1 year

Collaborators and Investigators

• Sponsor: Mauna Kea Technologies
• Investigators: Principal Investigator: Eric Barret, MD, Institut Mutualiste Montsouris

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 16, 2019
• Primary Completion (ANTICIPATED): June 1, 2020
• Study Completion (ANTICIPATED): June 1, 2020

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 18, 2018
• First Posted (ACTUAL): June 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 28, 2019
• Last Update Submitted That Met QC Criteria: January 24, 2019
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: MKT-2018-PERSEE-02; 2018-A01242-53 (OTHER: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No