Prostate Cancer
Conditions
Keywords
screening, magnetic resonance imaging, biomarker, mortality, stockholm3
Brief summary
This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.
Interventions
DIAGNOSTIC_TESTPSA/Stockholm3/MRI
Stockholm3+PSA followed by MRI of the prostate
DIAGNOSTIC_TESTPSA
PSA followed by standard biopsies
Sponsors
Swedish Cancer Foundation
The Swedish Research Council
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes are verified through national registers
Eligibility
Sex/Gender
MALE
Age
50 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
Eligible participants: -Men eligible for the longterm f/u-study arms (experimental and control) are participants in the STHLM3MRI trial. Inclusion Criteria: * Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61). * Permanent postal address in Stockholm * Not a previous participant in the Stockholm3 study (2012-2014)
Exclusion criteria
* Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia * Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia. * Men with a previous prostate biopsy the preceding 60 days before invitation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prostate cancer mortality | 5-10 years | Mortality from prostate cancer (yes/no) |
| Detection of clinically significant prostate cancer | 1-3 years | Gleason Score ≥7 disease detected (Yes/No) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performed prostate biopsy | 1-3 years | Participant undergone a biopsy procedure of the prostate (Yes/No) |
| Prostate cancer metastasis-free survival | 5-10 years | — |
| Grading of MRI prostate | 1-3 years | PI-RADS (Prostate Imaging Reporting and Data System (PI-RADS) ) score (1-5) |
| Performed MRI of prostate | 1-3 years | — |
| Detection of prostate cancer by grade | 1-3 years | ISUP (International Society of UroPathology) grade group 1-5 |
Countries
Sweden
Outcome results
None listed