CompletedNot Applicable

FFOCT for the Diagnosis of Prostate Cancer

France91 participantsStarted 2016-01-27

Plain-language 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

Who can participate

Age range45 Years – 75 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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)

Trial details

NCT IDNCT02394223

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-01-27

View on ClinicalTrials.gov More Patients With PSA Level 4.0 ng/mL trials