University Hospital Basel, Clinic of Urology
Basel, 4031, Switzerland
NCT Number: NCT03749993
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.
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Notify Me46 year–75 year
Male
Interventional
Not applicable
Basel, 4031, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Contraindications for MRI:
Use of bpMRI for opportunistic prostate cancer screening.
Time frame: 24 months
Total costs of the program
Time frame: 24 months
Total costs per patient
Time frame: 24 months
Number of follow-up interventions
Time frame: 24 months
Number of follow-up interventions
Time frame: 24 months
Number of follow-up interventions
Time frame: 24 months
Number of follow-up interventions
Time frame: 24 months
Number of follow-up interventions
Time frame: 24 months
Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case
Time frame: 24 months
"Distress Thermometer" score (0-10)
Time frame: 24 months
Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic
Time frame: 24 months
Number of patients needed to screen
Time frame: 24 months
Number of total consultations
University Hospital, Basel, Switzerland
Other
Acronym: VISIONING
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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