From PSA to Stockholm3: Study Part 1
PSA2STHLM3/1
From PSA to Stockholm3, a Naturalistic Effectiveness Multipart Research Program: Study Part 1
1 other identifier
observational
13,431
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2017
CompletedFirst Submitted
Initial submission to the registry
December 18, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2030
ExpectedApril 24, 2023
April 1, 2023
4.3 years
December 18, 2017
April 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Rate of prostate biopsies among patients tested with PSA and Stockholm3
9 to 12 months from september 2017 compared with a corresponding period one year earlier
Interventions
The new Stockholm3 test and traditional PSA test
Eligibility Criteria
All men at risk of prostate cancer in the 18 municipalities covered by Stavanger University Hospital
You may qualify if:
- All men where a physicians in regular clinical work finds that there is an indication to take the test
You may not qualify if:
- known prostate cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Helse Stavanger HFlead
- Karolinska Institutetcollaborator
Study Sites (1)
Stavanger University Hospital
Stavanger, Norway
Related Publications (1)
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.
PMID: 26563502BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Svein Kjosavik, MS PhD
Helse Stavanger HF
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 18, 2017
First Posted
December 21, 2017
Study Start
September 1, 2017
Primary Completion
December 31, 2021
Study Completion (Estimated)
December 31, 2030
Last Updated
April 24, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share