Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection (Bio-Prost)

In this study, we aim to evaluate the feasibility of anti-PSMA labelling to detect post-operative prostatic tissues by two ex vivo fluorescence techniques. We will evaluate the feasibility and detection of anti-PSMA labelling by:

1. / the FEMTO-ST institute medical device,
2. / the confocal microscope that will be used to measure fluorescence spectra of biological samples.

Study Overview

• Status: Terminated
• Conditions: Cancer Prostate
• Intervention / Treatment: Other: Fluorescence assessment

Detailed Description

For this protocol, 12 patients will be included.

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • Grenoble Alpes University Hospital
  • Grenoble, France, 38043
    • Grenoble Alpes University Hospital - Urology department

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patient with indication for radical prostatectomy

Description

Inclusion Criteria:

• male patient over 18 years old
• patient with indication for radical prostatectomy

• patient with a rectal palpable nodule or targeted MRI positive biopsies or with at least 4 positive biopsies in a hemi-prostate.

  • patient affiliated to French social security system or equivalent
  • patient who have signed a non-opposition form

Exclusion Criteria:

• patient with contraindication to radical prostatectomy
• patient with remedial prostatectomy
• patient with normal preoperative MRI or with absence of tumoral area
• patient with history of hormonal therapy
• person deprived of freedom by judicial or administrative decision
• person under legal protection
• person hospitalized for psychiatric care.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Experimental: fluorescence assessment; Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue.	Other: Fluorescence assessment; All subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for prostatic and non-prostatic tissue, as identified by anatomo-pathology (gold standard).	Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the fluorescence obtained using the FEMTO-ST device and the confocal microscope of anti-PSMA marked fresh prostate biopsies, for cancerous and non-cancerous tissue, as identified by anatomo-pathology (gold standard).	Fluorescence measurements obtained using the FEMTO-ST medical device and the confocal microscope.	14 months

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Clinical Investigation Centre for Innovative Technology Network; TIMC-IMAG
• Investigators: Principal Investigator: Jean Luc Descotes, MD, PhD, Grenoble Alpes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): October 7, 2018
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 15, 2017
• First Posted (Actual): May 17, 2017

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 11, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Medical device; Fluorescence imaging technique; Biopsies from resected prostate
• Other Study ID Numbers: 38RC17.019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No