Clinical trial NCT02394223: FFOCT for the Diagnosis of Prostate Cancer
Official title: Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients With PSA Level 4.0 ng/mL
Keywords: Cancer
Prostate
PSA
Biopsies
FFOCT procedure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2015-03-20
Enrollment: 91
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 45 to 75 years old, with PSA level 4.0 ng/mL

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the diagnosis performance of FFOCT for cancer detection in patients undergoing TRUS prostate biopsy, as compared to standard pathological evaluation
timeFrame: One day (biopsy procedure)
Secondary outcomes:
measure: To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy
timeFrame: One day (biopsy procedure)
measure: To evaluate the value of FFOCT for cancer characterization on prostate biopsy cores
timeFrame: One day (biopsy procedure)
measure: To evaluate the reproducibility of FFOCT evaluation for cancer detection on prostate biopsy cores
timeFrame: One day (biopsy procedure)
measure: To evaluate the learning curve of FFOCT evaluation on prostate biopsy cores
timeFrame: One day (biopsy procedure)
measure: To evaluate FFOCT procedure time
timeFrame: One day (biopsy procedure)
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris Cochin Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas Barry Delongchamps
role: PRINCIPAL_INVESTIGATOR
References: