Clinical trial · Observational
FFOCT for the Diagnosis of Prostate Cancer
Full Field Optical Coherence Tomography of Prostate Biopsies for the Diagnosis of Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Patients With PSA Level 4.0 ng/mL | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Full Field Optical Coherence Tomography (FFOCT) procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Full Field Optical Coherence Tomography (FFOCT) procedure
- interventionNames
- Procedure: Full Field Optical Coherence Tomography (FFOCT) procedure
Primary outcomes (1)
- 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)
- description
- Presence or absence of prostate cancer on pathological examination of prostate biopsy cores
Secondary outcomes (5)
- measure
- To evaluate the predictive values of FFOCT for cancer detection on prostate TRUS biopsy
- timeFrame
- One day (biopsy procedure)
- description
- the positive and negative predictive values for the presence of cancer, based on the prevalence of cancer in the population studied
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available