Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Swedish Cancer Foundation | OTHER |
| The Swedish Research Council | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Organized screening including repeat testing (MRI+biomarkers) | Experimental | participants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA>=3 | Stockholm3>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6 |
|
| One-time invitation to testing arm (traditional biopsies) | Active Comparator | participants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered. |
|
| Population controls | No Intervention | Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PSA/Stockholm3/MRI | Diagnostic Test | Stockholm3+PSA followed by MRI of the prostate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prostate cancer mortality | Mortality from prostate cancer (yes/no) | 5-10 years |
| Detection of clinically significant prostate cancer | Gleason Score ≥7 disease detected (Yes/No) | 1-3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Prostate cancer metastasis-free survival | 5-10 years | |
| Detection of prostate cancer by grade | ISUP (International Society of UroPathology) grade group 1-5 | 1-3 years |
Not provided
Eligible participants:
-Men eligible for the longterm f/u-study arms (experimental and control) are participants in the STHLM3MRI trial.
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tobias Nordström, Ass Prof | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Stockholm | Sweden |
Individual participant data underlying the results reported in this project will be available after deidentification, together with the study protocol, statistical analysis plan, and analytic code. Data will be made available to researchers who provide a methodologically robust proposal, in which the aims are relevant and clear. Proposals can be submitted up to 24 months after publication of the first main article of the project and should be directed to tobias.nordstrom@ki.se. Only proposals with ethical approval will be granted access to the data.
24 months from publication of first main manuscript of the project
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Outcomes are verified through national registers
| PSA | Diagnostic Test | PSA followed by standard biopsies |
|
| Performed prostate biopsy | Participant undergone a biopsy procedure of the prostate (Yes/No) | 1-3 years |
| Performed MRI of prostate | 1-3 years |
| Grading of MRI prostate | PI-RADS (Prostate Imaging Reporting and Data System (PI-RADS) ) score (1-5) | 1-3 years |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |