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
1 other identifier
interventional
804
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 16, 2020
CompletedFirst Submitted
Initial submission to the registry
February 2, 2020
CompletedFirst Posted
Study publicly available on registry
March 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2022
CompletedMarch 2, 2020
February 1, 2020
2.1 years
February 2, 2020
February 27, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Rate of overall prostate cancer and significant prostate cancer between the groups according to the location of the lesions.
2 years
Rate of overall prostate cancer and significant prostate cancer between the groups according to the size of the lesions.
2 years
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
Rate of overall prostate cancer and significant prostate cancer between the groups according to the prostate volume.
2 years
Study Arms (2)
0: cognitive
EXPERIMENTALtarget prostate biopsies by cognitive fusion
1: software
EXPERIMENTALtarget prostate biopsies by software
Interventions
Eligibility Criteria
You may qualify if:
- Age over 40 years.
- mpMRI carried out in our center.
- Presence of lesions with PIRADSv.2 ≥ 3.
- Acceptance to participate in the study.
You may not qualify if:
- PSA\> 30 ng / ml
- Treatment with 5-ARIs (5-alpha-reductase inhibitors).
- Previous diagnosis of PCa.
- TR\> T3.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Study Officials
- PRINCIPAL INVESTIGATOR
Ana Celma, MD
Hospital Vall d'Hebron, Barcelona
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2020
First Posted
March 2, 2020
Study Start
January 16, 2020
Primary Completion
February 27, 2022
Study Completion
February 27, 2022
Last Updated
March 2, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share