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

Mauna Kea Technologies

Status: Unknown

Conditions: Prostate Cancer

Treatments: Device: Confocal Laser Endomicroscopy

Study type: Interventional

Funder types: Industry

Identifiers

NCT03561857

MKT-2018-PERSEE-02

2018-A01242-53 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Confocal Laser Endomicroscopy

Experimental group

Description:

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

Treatment:

Device: Confocal Laser Endomicroscopy