Clinical trial NCT03561857: Clinical Trial for a Robotic Endomicroscopy to Better Define Resection Strategies Applied to Urology Surgery
Official title: Essais Clinique Pour Une Endomicroscopie Robotisée Dans la redéfinition Des Stratégies d'ExérèsE (PERSÉE) appliquée à la Chirurgie de la Prostate
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Mauna Kea Technologies
Sponsor class: INDUSTRY
First posted: 2018-06-19
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: pCLE criteria
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Ease of use of the endomicroscopy device
timeFrame: 1 year
measure: Audio/video telecommunication quality
timeFrame: 1 year
measure: Number of participants with CLE imaging-related adverse events as assessed by CTCAE v5.0
timeFrame: 1 year
measure: Stability and reproducibility of images/sequences during procedures
timeFrame: 1 year
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint-Simon
city: Paris
country: France
facility: Institut Mutualiste Montsouris
Study officials:
affiliation: Institut Mutualiste Montsouris
name: Eric Barret, MD
role: PRINCIPAL_INVESTIGATOR
References: