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

NCT ID: NCT07206693

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 257275 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-01
• Study Completion Date: 2023-12-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Men aged 75-79 living in Stockholm from 2007-2023

Prostate specific antigen (PSA)

Intervention Type: DIAGNOSTIC_TEST

Prostate specific antigen (PSA) for prostate cancer screening

Interventions

Prostate specific antigen (PSA)

Prostate specific antigen (PSA) for prostate cancer screening

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 75 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Tobias Nordström

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Nordström, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Stockholm, , Sweden

Countries

Sweden

Other Identifiers

2012/438-31/3

Identifier Type: -

Identifier Source: org_study_id