Fusion Prostate Biopsy, Prostate Cancer Detection
Conditions
Keywords
prostate biopsy, mpMRI
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.
Interventions
DIAGNOSTIC_TESTcognitive vs software
cognitive vs software
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall prostate cancer and significant prostate cancer between the groups | 2 years | Differences in percentage of detection of overall prostate cancer and prostate cancer ISUP equal or greater than 2 between both groups will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions. | 2 years | 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. |
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions. | 2 years | 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. |
| 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. | 2 years | 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. |
| Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume. | 2 years | 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. |
Countries
Spain
Contacts
Primary ContactAna Celma, MD
Backup ContactIgnasi Gallardo, Ph
Outcome results
None listed