FFOCT for the Diagnosis of Prostate Cancer

Study Overview
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Brief Summary
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Primary objective : The primary objective is to evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation. Secondary objective: Evaluate predictive values of FFOCT for cancer detection on prostate biopsy cores Evaluate the value of FFOCT for cancer characterization on prostate biopsy cores Evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores Evaluate the learning curve of FFOCT evaluation on prostate biopsy cores Evaluate FFOCT procedure time

Detailed Description
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Research in optical imaging has led to the development of the Full Field Optical Coherence Tomography (FFOCT) technology, which allows to image fresh tissues up to a depth of a few hundreds microns. The system is a microscope coupled with an interferometer. A halogen light source is used to illuminate the tissue specimen and a reference mirror. The light retro diffused by the specimen is combined with the light reflected by the mirror, and the interference signal is measured. Multiple Grey scale images are obtained and automatically stitched to obtain a complete slide throughout the specimen. The feasibility of the technique has been reported in various pilot studies, as well as the absence of any potential tissue harm and subsequent pathological artifact caused by the process. FFOCT could be used as an additional detection tool for prostate cancer screening. The use of extended systematic trans-rectal ultrasound-guided (TRUS) prostate biopsies has led to over-diagnosis and over-treatment. Also, the number of unnecessary biopsies has increased, along with the morbidity of the procedure. Performing a pre-pathological evaluation of biopsy cores during the biopsy procedure would be of significant help to determine the nature of targeted areas and guide the number of biopsies to perform. We hypothesize that FFOCT imaging of prostate biopsy cores would allow a cancer detection rate not statistically different from pathological analysis.

Official Title
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Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer

Conditions
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Patients With PSA Level 4.0 ng/mL

Intervention / Treatment
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* Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patient aged 45 to 75 years old included - PSA level 4.0 ng/mL - Patient referred for trans rectal ultrasound-guided prostate biopsy with additional MRI-targeted biopsies - Patient no opposed to participate in the study Patient affiliated to the French National Social Security System Exclusion Criteria: Known prostate cancer Patients unable to understand the course of the study

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 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 |
| --- | --- |
| Full Field Optical Coherence Tomography (FFOCT) procedure<br> | Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure<br>* TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation | Presence or absence of prostate cancer on pathological examination of prostate biopsy cores | One day (biopsy procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy | the positive and negative predictive values for the presence of cancer, based on the prevalence of cancer in the population studied | One day (biopsy procedure) | 
| To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores | Gleason score and cancer length of prostate cancer on pathological examination of each prostate biopsy cores | One day (biopsy procedure) | 
| To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores | the inter observer agreement for the diagnosis of cancer between 2 experienced pathologists fully trained to the technique, as well as 2 experienced urologists trained to the technique | One day (biopsy procedure) | 
| To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores | the evolution of the diagnostic performance with time when FFOCT images are evaluated with an experienced pathologist untrained to the technique before the beginning of the study | One day (biopsy procedure) | 
| To evaluate FFOCT procedure time | the duration of FFOCT procedure | One day (biopsy procedure) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Prostate, PSA, Biopsies, FFOCT procedure