Patients With PSA Level 4.0 ng/mL
Conditions
Keywords
Cancer, Prostate, PSA, Biopsies, FFOCT procedure
Brief summary
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
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.
Interventions
PROCEDUREFull Field Optical Coherence Tomography (FFOCT) procedure
TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation | One day (biopsy procedure) | Presence or absence of prostate cancer on pathological examination of prostate biopsy cores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy | One day (biopsy procedure) | the positive and negative predictive values for the presence of cancer, based on the prevalence of cancer in the population studied |
| To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores | One day (biopsy procedure) | Gleason score and cancer length of prostate cancer on pathological examination of each prostate biopsy cores |
| To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores | One day (biopsy procedure) | 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 |
| To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores | One day (biopsy procedure) | 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 |
| To evaluate FFOCT procedure time | One day (biopsy procedure) | the duration of FFOCT procedure |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNicolas Barry Delongchamps
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed