Comparison of Prostate Fusion Biopsies With Software and Cognitive

Prostate Cancer Detection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04291742
• Other study ID #: PR(AG)161/2019
• Status: Recruiting
• Phase: N/A
• Start date: January 16, 2020
• Est. completion date: February 27, 2022

Study information

• Verified date: February 2020
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: Ana Celma, MD
• Phone: 0034932746000
• Email: acelma[@]vhebron.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 804
• Est. completion date: February 27, 2022
• Est. primary completion date: February 27, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fusion Prostate Biopsy
• Prostate Cancer Detection
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• cognitive vs software
cognitive vs software

Locations

Country	Name	City	State
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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