Evaluation of a MRI-based Prostate Cancer Screening Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a MRI-based Prostate Cancer Screening Program

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: Screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 46 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Screening Arm<br>Screening | Other: Screening<br>* Use of bpMRI for opportunistic prostate cancer screening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total costs of the MRI based prostate cancer screening | Total costs of the program | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of costs of classical screening based on PSA and DRE | Total costs per patient | 24 months | 
| number of patients undergoing active surveillance | Number of follow-up interventions | 24 months | 
| number of patients undergoing radical cystoprostatectomy | Number of follow-up interventions | 24 months | 
| number of patients undergoing radiotherapy | Number of follow-up interventions | 24 months | 
| number of patients undergoing androgen deprivation therapy | Number of follow-up interventions | 24 months | 
| number of patients undergoing chemotherapy | Number of follow-up interventions | 24 months | 
| Quality of Life (Qol) | Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case | 24 months | 
| Distress Thermometer Assessment | Distress Thermometer score (0-10) | 24 months | 
| AI Evaluation | Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic | 24 months | 
| Number of patients | Number of patients needed to screen | 24 months | 
| Number of consultations | Number of total consultations | 24 months |