Status:
COMPLETED
Evaluation of a MRI-based Prostate Cancer Screening Program
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Prostate Cancer
Eligibility:
MALE
46-75 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.
Detailed Description
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening. According to European guidelines we will include men \> 50 years of age and men \>45 year...
Eligibility Criteria
Inclusion
- well-informed men with the wish for prostate cancer screening
- prostate biopsy naïve
- life expectancy \> 10 years
- men \> 50 years of age
- men \> 45 years of age with a family history of prostate cancer
- African-Americans \> 45 years of age
Exclusion
- prostate biopsy performed prior to study
- life expectancy \< 10 years
- acute urinary tract infection
- NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment)
- IPSS score 20 (leads to initiation of urologic diagnostics and treatment)
- Contraindications for MRI:
- Heart pacemaker
- Artificial heart valves (some types are eligible)
- Cochlea implant
- ICD
- Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.)
- Severe claustrophobia
Key Trial Info
Start Date :
January 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2023
Estimated Enrollment :
241 Patients enrolled
Trial Details
Trial ID
NCT03749993
Start Date
January 10 2019
End Date
May 1 2023
Last Update
May 23 2023
Active Locations (1)
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1
University Hospital Basel, Clinic of Urology
Basel, Switzerland, 4031