Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies (STHLM3MR-2)

Karolinska Institute

Status: Active, not recruiting

Conditions: Prostate Cancer

Treatments: Procedure: Systematic biopsies; Procedure: MRI/Fusion biopsies

Study type: Interventional

Funder types: Other

Identifiers

NCT03377881

STHLM3MR-2

Details and patient eligibility

About

The STHLM3-MRI trial is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context.

The study includes individualised repeat invitations for re-screening to participants not diagnosed with prostate cancer.

Full description

The overarching strategy of the STHLM3-MR/Fusion projects are to study an improved diagnostic pipeline including an improved blood-based test for identification of men with increased risk of prostate cancer and use of MRI to select men for diagnostic workup with targeted prostate biopsies. The aim is to increase the specificity in early detection of prostate cancer without decreasing the sensitivity of aggressive prostate cancers.

The primary endpoints are the number of performed biopsies, the number of performed MRI and the number of detected high-risk prostate cancers. Secondary endpoints include the number of low risk prostate cancers diagnosed and the proportion of patients with up-or downgraded disease after assessment of prostatectomy specimen. Additional aims include to assess the health economic consequences and development of automated image-analysis.

The STHLM3-MR project is performed in two separate phases, analyzed separately. STHLM3-MR Phase 1 closed inclusion 2017-06-01. All participants underwent target and systematic biopsies together with STHLM3 test analysis. The study is constitutes a current practice cohort and levels of the STHLM3 test were not used for selecting participants.

STHLM3-MR Phase 2 is a study comparing traditional prostate cancer detection using PSA and systematic biopsies with the improved pipeline for prostate cancer detection using the STHLM3 test and targeted biopsies in a screening context. STHLM3-MR Phase 2 reported outcomes from the first screening round 2023. Repeated screening with individualised screening intervals will be offered to participants without prostate cancer detected.

Enrollment: 12,750 patients

Sex: Male

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Permanent postal address in Stockholm

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12,750 participants in 2 patient groups

Standard arm (One testing with PSA and standard biopsy)

Other group

Description:

The traditional/control arm consists of PSA testing and if PSA\>3ng/ml a systematic biopsy of the prostate is performed. Only one screening is offered for participants.

Treatment:

Procedure: Systematic biopsies

STHLM3+MRI/Fusion including repeat screening.

Experimental group

Description:

The experimental arm consists of a Stockholm3 bloodiest and if elevated, an MRI is recommended with targeted biopsies to prostate lesions. Participants with PSA\<1.5ng/ml are reinvented for prescreen after 6 years. Remaining participants with no prostate cancer detected are reinvited for re-screen at 2-3 years.

Treatment:

Procedure: MRI/Fusion biopsies