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Active, not recruiting

NCT Number: NCT07155759

Long-term Outcomes of Prostate Cancer Screening

This study is an expansion of the screening-by-invitation STHLM3MRI trial for detection of prostate cancer. In summary, we assess longterm outcomes (prostate cancer mortality, incidence and resource use) in men (i) invited and randomized to a screening program using PSA, a biomarker test and MRI; (ii) invited and randomized to a single PSA test with prostate biopsies followed by opportunistic testing and (iii) population controls. Mortality is verified through register data, disease verification is made through in-study biopsy results and registry data.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–74 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Karolinska Institutet

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Eligible participants:

-Men eligible for the longterm f/u-study arms (experimental and control) are participants in the STHLM3MRI trial.

Inclusion criteria

  • Men age 50-74 years without prior diagnosis of prostate cancer (ICD-9 C61).
  • Permanent postal address in Stockholm
  • Not a previous participant in the Stockholm3 study (2012-2014)

Exclusion criteria

  • Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
  • Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
  • Men with a previous prostate biopsy the preceding 60 days before invitation.

Treatment and study plan

PSA/Stockholm3/MRI

Diagnostic Test

Stockholm3+PSA followed by MRI of the prostate

PSA

Diagnostic Test

PSA followed by standard biopsies

Primary outcomes

  1. Prostate cancer mortality

    Time frame: 5-10 years

    Mortality from prostate cancer (yes/no)

  2. Detection of clinically significant prostate cancer

    Time frame: 1-3 years

    Gleason Score ≥7 disease detected (Yes/No)

Secondary outcomes

  1. Prostate cancer metastasis-free survival

    Time frame: 5-10 years

  2. Detection of prostate cancer by grade

    Time frame: 1-3 years

    ISUP (International Society of UroPathology) grade group 1-5

  3. Performed prostate biopsy

    Time frame: 1-3 years

    Participant undergone a biopsy procedure of the prostate (Yes/No)

  4. Performed MRI of prostate

    Time frame: 1-3 years

  5. Grading of MRI prostate

    Time frame: 1-3 years

    PI-RADS (Prostate Imaging Reporting and Data System (PI-RADS)

    ) score (1-5)

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Swedish Cancer Foundation
  • The Swedish Research Council

Registry information

Official study title

Long-term Outcomes of Prostate Cancer Screening Using PSA, Biomarkers and MRI: The STHLM3MRI Trial

Acronym: STHLM3MRI_3

Important dates

Study start
2024
Primary completion
2025
Study completion
2035
First posted
Sep 4, 2025
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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