Prostate Cancer Clinical Trial
— PSA2STHLM3/1Official title:
From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1
Verified date | April 2023 |
Source | Helse Stavanger HF |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This part of the project aims to analyze the effectiveness of the Stockholm3 test in regular clinical practice, both in general practice and in the specialist health care, as a tool for detecting patients who need further diagnostics for prostate cancer.
Status | Active, not recruiting |
Enrollment | 13431 |
Est. completion date | December 31, 2030 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All men where a physicians in regular clinical work finds that there is an indication to take the test Exclusion Criteria: - known prostate cancer |
Country | Name | City | State |
---|---|---|---|
Norway | Stavanger University Hospital | Stavanger |
Lead Sponsor | Collaborator |
---|---|
Helse Stavanger HF | Karolinska Institutet |
Norway,
Gronberg H, Adolfsson J, Aly M, Nordstrom T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M. Prostate cancer screening in men aged 50-69 years (STHLM3): a prospective population-based diagnostic study. Lancet Oncol. 2015 Dec;16(16):1667-76. doi: 10.1016/S1470-2045(15)00361-7. Epub 2015 Nov 10. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of prostate cancer with Gleason score = 7 / Gleason score = 6 | The percentage of patients whose prostate biopsies showed a Gleason score = 6 or =7 among those referred for diagnostics based on a PSA test or a Stockholm3 test | 9 to 12 months from september 2017 compared with a corresponding period one year earlier | |
Secondary | Rate of prostate biopsies among patients tested with PSA and Stockholm3 | The percentage of patients referred for further diagnosis of potential prostate cancer with biopsy among those who were tested with PSA over a period of time, compared to those tested with Stockholm3 for a corresponding period of time | 9 to 12 months from september 2017 compared with a corresponding period one year earlier |
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