Comparison of Prostate Fusion Biopsies With Software and Cognitive

Study Overview
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Brief Summary
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This study evaluates the efficacy to diagnose significant prostate cancer in patients with suspicious lesions in mpMRI (multiparametric magnetic resonance imaging) by comparing prostate biopsies performed by cognitive fusion with respect to those performed with software fusion (BK-fusion®). Half of the patients included will undergo a systematic prostate biopsy + target biopsies by cognitive fusion and the other half of the population, will undergo a systematic prostate biopsy + target biopsies by software fusion.

Detailed Description
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Various techniques have been developed to perform targeted prostate biopsies aimed at suspicious lesions detected in mpMRI. The two most frequently used are cognitive fusion, in which the physician locates the areas where the mpMRI detects suspicious lesions and directs the puncture by ultrasound; and software fusion, in which the images of the mpMRI are integrated by a software with the ultrasound allowing to direct the puncture to the lesion itself. Both forms of fusion biopsy have proven to be superior to systematized prostate biopsies in the detection of significant prostate cancer, although neither has demonstrated superiority over the other.

Official Title
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Prospective and Randomized Study to Compare the Efficacy of Cognitive Fusion Prostate Biopsies and Prostate Biopsies Performed by BK-fusion® Software, for the Diagnosis of Significant Prostate Cancer

Conditions
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Prostate Cancer Detection, Fusion Prostate Biopsy

Intervention / Treatment
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* Diagnostic Test: cognitive vs software


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 40 years. mpMRI carried out in our center. Presence of lesions with PIRADSv.2 ≥ 3. Acceptance to participate in the study. Exclusion Criteria: PSA> 30 ng / ml Treatment with 5-ARIs (5-alpha-reductase inhibitors). Previous diagnosis of PCa. TR> T3.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0: cognitive<br>target prostate biopsies by cognitive fusion | Diagnostic Test: cognitive vs software<br>* cognitive vs software<br>|
| Experimental: 1: software<br>target prostate biopsies by software | Diagnostic Test: cognitive vs software<br>* cognitive vs software<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of overall prostate cancer and significant prostate cancer between the groups | Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions. | Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the location of the lesions. | 2 years | 
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions. | Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the size of the lesions. | 2 years | 
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the PIRADS (prostate imaging and reporting and data System) of the lesions. | Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the PIRADS (prostate imaging and reporting and data System) of the lesions. | 2 years | 
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume. | Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed according to the prostate volume. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate biopsy, mpMRI