Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

Study Overview
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Brief Summary
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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: / the FEMTO-ST institute medical device, / the confocal microscope that will be used to measure fluorescence spectra of biological samples.

Detailed Description
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For this protocol, 12 patients will be included.

Official Title
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Assessment of a New Fluorescence Imaging Technique Using Biopsies From Prostate Resection

Conditions
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Cancer Prostate

Intervention / Treatment
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* Other: Fluorescence assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fluorescence assessment<br>Medical device: Use of the FEMTO-ST institute medical device to detect prostatic and non prostatic tissue. | Other: Fluorescence assessment<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluorescence imaging technique, Biopsies from resected prostate, Medical device