Long-term Outcomes of Prostate Cancer Screening

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT07155759
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-27
• Last Update Submitted: 2025-08-27
• Study First Posted: 2025-09-04
• Last Update Posted: 2025-09-04
• Primary Completion: 2025-10-01
• Study Completion: 2035-11-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 7500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prostate cancer mortality	5-10 years	Mortality from prostate cancer (yes/no)
Detection of clinically significant prostate cancer	1-3 years	Gleason Score ≥7 disease detected (Yes/No)

Secondary Outcome Measures

Name	Time	Method
Prostate cancer metastasis-free survival	5-10 years
Detection of prostate cancer by grade	1-3 years	ISUP (International Society of UroPathology) grade group 1-5
Performed prostate biopsy	1-3 years	Participant undergone a biopsy procedure of the prostate (Yes/No)
Performed MRI of prostate	1-3 years
Grading of MRI prostate	1-3 years	PI-RADS (Prostate Imaging Reporting and Data System (PI-RADS); ) score (1-5)

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden