Long-term Outcomes of Prostate Cancer Screening

NCT07155759 | Active Not Recruiting DMC

• 1 other identifier: STHLM3MRI_3
• Study Type: interventional
• Target: 7,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

screening; magnetic resonance imaging; biomarker; mortality; stockholm3

Outcome Measures

Primary Outcomes (2)

• Prostate cancer mortality

  Mortality from prostate cancer (yes/no)

  5-10 years

• Detection of clinically significant prostate cancer

  Gleason Score ≥7 disease detected (Yes/No)

  1-3 years

Secondary Outcomes (5)

• Prostate cancer metastasis-free survival

  5-10 years

• Detection of prostate cancer by grade

  1-3 years

• Performed prostate biopsy

  1-3 years

• Performed MRI of prostate

  1-3 years

• Grading of MRI prostate

  1-3 years

Study Arms (3)

Organized screening including repeat testing (MRI+biomarkers)

EXPERIMENTAL

participants are offered prostate cancer screening. Interventions are (i) a paired PSA and Stockholm3 bloodtest; (ii) if elevated (PSA\>=3 \| Stockholm3\>=0.11), an MRI is offered. If MRI shows PI-RADS≥3, prostate biopsies are offered. Screenings are offered at year 0, year 2-3 (if original PSA≥1.5) and year 6

Diagnostic Test: PSA/Stockholm3/MRI

One-time invitation to testing arm (traditional biopsies)

ACTIVE COMPARATOR

participants are offered prostate cancer screening. interventions are a PSA bloodtest. If PSA≥3 ng/ml, a standard prostate biopsy is offered. No repeat screenings are offered.

Diagnostic Test: PSA

Population controls

NO INTERVENTION

Population controls are identified through registers and followed in national outcome registers (Swedish Board of Health and Welfare)

Interventions

PSA/Stockholm3/MRI DIAGNOSTIC_TEST

Stockholm3+PSA followed by MRI of the prostate

Organized screening including repeat testing (MRI+biomarkers)

PSA DIAGNOSTIC_TEST

PSA followed by standard biopsies

One-time invitation to testing arm (traditional biopsies)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Swedish Cancer Foundation: collaborator
• The Swedish Research Council: collaborator

Study Sites (1)

Karolinska Institutet

Stockholm, Sweden

Location

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, Ass Prof

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are verified through national registers
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Consultant Urologist

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 4, 2025
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): November 1, 2035
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 24 months from publication of first main manuscript of the project

Locations

SE (1)