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Impact of PSA-based Screening on Mortality Among Men Aged 75-79: Target Trial Emulation

NCT07206693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 257275

Last updated 2025-10-03

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer
  • Prostate Cancer Screening
  • Prostate Cancer Screening Decision
  • Prostate Specific Antigen Screening

Interventions

DIAGNOSTIC_TEST

Prostate specific antigen (PSA)

Prostate specific antigen (PSA) for prostate cancer screening

Sponsors & Collaborators

Principal Investigators

  • Tobias Nordström, MD PhD · Karolinska Institutet

Eligibility

Min Age
75 Years
Max Age
79 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-01-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206693 on ClinicalTrials.gov