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

NCT07206693 | Completed

• 1 other identifier: 2012/438-31/3
• Study Type: observational
• Target: 257,275
• Locations: 1 country
• Sites: 1

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

Keywords

prostate cancer; screening; prostate specific antigen; older adults; urology; mortality; emulation of target trial

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  17 years

• Prostate-cancer specific mortality

  17 years

Study Arms (1)

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

Diagnostic Test: Prostate specific antigen (PSA)

Interventions

Prostate specific antigen (PSA) DIAGNOSTIC_TEST

Prostate specific antigen (PSA) for prostate cancer screening

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

Eligibility Criteria

• Age: 75 Years - 79 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study and the target-trial emulation will use population-based register data of men living in Stockholm between 2007-2023 screened for prostate cancer, extracted from the Stockholm Prostate Cancer Diagnostics Register (STHLM0). STHLM0 has complete PSA test records since 1 January 2007. This will be supplemented with information on non-tested men from the STHLM0+ register. Demographic information, family history of prostate cancer, diagnoses, hospitalization, specialized outpatient healthcare, prostate cancer treatment, and mortality information are provided from the linked Swedish population registers

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Unknown Facility

Stockholm, Sweden

Location

Related Publications (1)

• Abbadi A, Micoli C, Discacciati A, Olarte Parra C, Lantz A, Bjornebo L, Arvendell M, Chandra Engel J, Andersson J, Falagario U, Gronberg H, Eklund M, Clements M, Nordstrom T. Can Prostate Cancer Screening Reduce Mortality in Men Aged 75-79 Years? A Protocol for Target-trial Emulation. Eur Urol Open Sci. 2025 Nov 6;82:147-154. doi: 10.1016/j.euros.2025.10.016. eCollection 2025 Dec.

  PMID: 41280154 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tobias Nordström, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 17 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2007
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)