Long-term Outcomes of Prostate Cancer Screening (STHLM3MRI_3)

Karolinska Institute

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Diagnostic Test: PSA/Stockholm3/MRI; Diagnostic Test: PSA

Study type: Interventional

Funder types: Other

Identifiers

NCT07155759

STHLM3MRI_3

Details and patient eligibility

About

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.

Enrollment: 7,500 estimated patients

Sex: Male

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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7,500 participants in 3 patient groups

Organized screening including repeat testing (MRI+biomarkers)

Experimental group

Description:

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

Treatment:

Diagnostic Test: PSA/Stockholm3/MRI

One-time invitation to testing arm (traditional biopsies)

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: PSA

Population controls

No Intervention group

Description:

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