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.
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 years of age and a family history of PCA as well as African-Americans \>45 years of age. In this study, bpMRI will be used for opportunistic prostate cancer screening. The indication for prostate biopsy is based solely on the results of bpMRI. In case of detection of lesions suspicious for prostate cancer ( PIRADS 3), targeted MRI-TRUS fusion biopsy with 3 biopsies per lesion will be performed. In case no lesions suspicious for PCA ( PIRADS 3) are detected, SB will performed if PSA exceeds 10ng/ml and/or DRE is suspicious for PCA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
241
Use of bpMRI for opportunistic prostate cancer screening.
University Hospital Basel, Clinic of Urology
Basel, Switzerland
Total costs of the MRI based prostate cancer screening
Total costs of the program
Time frame: 24 months
Comparison of costs of classical screening based on PSA and DRE
Total costs per patient
Time frame: 24 months
number of patients undergoing active surveillance
Number of follow-up interventions
Time frame: 24 months
number of patients undergoing radical cystoprostatectomy
Number of follow-up interventions
Time frame: 24 months
number of patients undergoing radiotherapy
Number of follow-up interventions
Time frame: 24 months
number of patients undergoing androgen deprivation therapy
Number of follow-up interventions
Time frame: 24 months
number of patients undergoing chemotherapy
Number of follow-up interventions
Time frame: 24 months
Quality of Life (Qol)
Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case
Time frame: 24 months
Distress Thermometer Assessment
"Distress Thermometer" score (0-10)
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Time frame: 24 months
AI Evaluation
Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic
Time frame: 24 months
Number of patients
Number of patients needed to screen
Time frame: 24 months
Number of consultations
Number of total consultations
Time frame: 24 months