Comparison of Prostate Fusion Biopsies With Software and Cognitive

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Fusion Prostate Biopsy; Prostate Cancer Detection

Treatments: Diagnostic Test: cognitive vs software

Study type: Interventional

Funder types: Other

Identifiers

NCT04291742

PR(AG)161/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 804 estimated patients

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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804 participants in 2 patient groups

0: cognitive

Experimental group

Description:

target prostate biopsies by cognitive fusion

Treatment:

Diagnostic Test: cognitive vs software

1: software

Experimental group

Description:

target prostate biopsies by software

Treatment:

Diagnostic Test: cognitive vs software