Prostate Cancer
Conditions
Brief summary
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
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.
Interventions
OTHERScreening
Use of bpMRI for opportunistic prostate cancer screening.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
46 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total costs of the MRI based prostate cancer screening | 24 months | Total costs of the program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress Thermometer Assessment | 24 months | Distress Thermometer score (0-10) |
| AI Evaluation | 24 months | Evaluation of algorithms (AI) for CAD MRI based PCA diagnostic |
| Number of patients | 24 months | Number of patients needed to screen |
| Number of consultations | 24 months | Number of total consultations |
| number of patients undergoing androgen deprivation therapy | 24 months | Number of follow-up interventions |
| Quality of Life (Qol) | 24 months | Qol Questionnaire (SF- 36) score (0-100), 0 means best, 100 worst case |
| Comparison of costs of classical screening based on PSA and DRE | 24 months | Total costs per patient |
| number of patients undergoing active surveillance | 24 months | Number of follow-up interventions |
| number of patients undergoing radical cystoprostatectomy | 24 months | Number of follow-up interventions |
| number of patients undergoing radiotherapy | 24 months | Number of follow-up interventions |
| number of patients undergoing chemotherapy | 24 months | Number of follow-up interventions |
Countries
Switzerland
Outcome results
None listed