NCT07206693Completed
Impact of PSA-based Screening on Mortality Among Men Aged 75-79: Target Trial Emulation
Source: ClinicalTrials.gov · Last updated 3 Oct 2025
Brief summary (registry, in English)
Opportunistic prostate-specific antigen (PSA) testing is widespread among men aged 75-79. Current American and European guidelines recommend PSA-based screening through shared decision-making if men are expected to live at least 10 more years-a threshold previously tied to ages 70-74. With rising life expectancy, Swedish men aged 75-79 now exceed this benchmark, averaging over 10 years. Since no randomized controlled trials have examined screening in this age group, this study will use data from the Stockholm Prostate Cancer Diagnostics Register (2007-2023) to emulate a target trial. Men without prior prostate cancer will be assigned to screened or unscreened groups based on PSA test records and followed until death or December 2023. Analyses will use survival models, cumulative incidence functions, and sensitivity checks (e.g., varying follow-up duration, calendar year vs. age enrollment, and comparisons with men aged 65-69). The goal is to determine whether PSA screening at ages 75-79 improves overall and prostate cancer-specific survival, and whether guidelines should expand to include this group while balancing the risk of overdiagnosis. Results will inform both clinical practice and the design of future randomized trials.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 257275 (actual)
- First submitted
- 26 Sept 2025
- Start date
- 1 Jan 2007
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Karolinska Institutet
- Diseases
- Prostate cancer
- NCT number
- NCT07206693
What you commit to
- Study type: Observational
- Participants enrolled: 257275
- From 1 Jan 2007 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Men younger than 75 or older than 79 between 2007-2023. Have prostate cancer diagnosis at the time of inclusion (based on each trial emulation) Missing data on the exposure, outcomes, and confounders.
Who the study is looking for
- Men aged 75-79 between 2007-2023, with no prostate cancer diagnosis at the time of inclusion (based on each trial emulation) will be considered eligible for the trials. To ensure proper control for potential confounding, and to be able to evaluate the eligibility criteria, only men with complete information on their screening status, outcomes, and confounders in the registers will be included.
Age in the registry: 75 years to 79 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Stockholm | Sweden | Unknown status |
Related publications
- Can Prostate Cancer Screening Reduce Mortality in Men Aged 75-79 Years? A Protocol for Target-trial Emulation.Eur Urol Open Sci · 2025 · PMID 41280154
This page is information, not medical advice. Discuss any trial with your doctor.