Trials / Unknown
UnknownNCT04291742
Comparison of Prostate Fusion Biopsies With Software and Cognitive
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 804 (estimated)
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | cognitive vs software | cognitive vs software |
Timeline
- Start date
- 2020-01-16
- Primary completion
- 2022-02-27
- Completion
- 2022-02-27
- First posted
- 2020-03-02
- Last updated
- 2020-03-02
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04291742. Inclusion in this directory is not an endorsement.