Clinical trial NCT04291742: Comparison of Prostate Fusion Biopsies With Software and Cognitive
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer Detection
Fusion Prostate Biopsy
Keywords: prostate biopsy
mpMRI
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-03-02
Enrollment: 804
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of overall prostate cancer and significant prostate cancer between the groups
timeFrame: 2 years
Secondary outcomes:
measure: Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions.
timeFrame: 2 years
measure: Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
measure: Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume.
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
Study officials:
affiliation: Hospital Vall d'Hebron, Barcelona
name: Ana Celma, MD
role: PRINCIPAL_INVESTIGATOR
References: