An interventional study of Screening in Prostate Cancer, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to male participants aged 46 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-23.
Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Screening
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 241 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contraindications for MRI:
Screening
Other: Screening
Use of bpMRI for opportunistic prostate cancer screening.
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)
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Basel, Switzerland