FFOCT for the Diagnosis of Prostate Cancer (BIOMAGIC01)

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

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

Study Overview

• Status: Completed
• Conditions: Patients With PSA Level 4.0 ng/mL
• Intervention / Treatment: Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure

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.

• Study Type: Observational
• Enrollment (Actual): 91

Contacts and Locations

Study Locations

• France
  • Paris, France, 75014
    • Assistance Publique - Hôpitaux de Paris Cochin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 45 to 75 years old, with PSA level 4.0 ng/mL

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Nicolas Barry Delongchamps, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2016
• Primary Completion (Actual): January 27, 2017
• Study Completion (Actual): January 27, 2017

Study Registration Dates

• First Submitted: March 16, 2015
• First Submitted That Met QC Criteria: March 16, 2015
• First Posted (Estimate): March 20, 2015

Study Record Updates

• Last Update Posted (Actual): March 19, 2018
• Last Update Submitted That Met QC Criteria: March 16, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Cancer; PSA; Prostate; Biopsies; FFOCT procedure
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: AOK 13142