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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Screening Arm | Other | Screening |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening | Other | Use of bpMRI for opportunistic prostate cancer screening. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total costs of the MRI based prostate cancer screening | Total costs of the program | 24 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Contraindications for MRI:
Informed men at risk for prostate cancer will be included into the study to undergo prostate cancer screening.
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| Name | Affiliation | Role |
|---|---|---|
| Cyrill Rentsch, MD PHD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel, Clinic of Urology | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |