Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies

Not Applicable

Active, not recruiting

• Conditions: Prostate Cancer
• Interventions: Procedure: Systematic biopsies; Procedure: MRI/Fusion biopsies

• Registration Number: NCT03377881
• Lead Sponsor: Karolinska Institutet

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-13
• Study First Posted: 2017-12-19
• Study Start: 2018-04-04
• Primary Completion: 2020-12-10
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-26
• Study Completion: 2030-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 12750

Inclusion Criteria

• Permanent postal address in Stockholm

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard arm (One testing with PSA and standard biopsy)	Systematic biopsies	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.
STHLM3+MRI/Fusion including repeat screening.	MRI/Fusion biopsies	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.

Primary Outcome Measures

Name	Time	Method
Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen	At 2 months after completing first screening round (included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).	Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm

Secondary Outcome Measures

Name	Time	Method
Number of performed MRI in the study arms	At 2 months after completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).	Number of performed prostate MRI procedures counted per study arm
Number of performed biopsy procedures in the study arms	At 2 months after completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).	Number of performed prostate biopsy procedures counted per study arm
Distribution of MRI findings in men positive for Stockholm3 and/or PSA	At 2 months after completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).	Distribution of PI-RADS (Prostate Imaging-Reporting and Data System; 1-5; 5=clinically significant cancer is highly likely to be present) scores among men undergoing an MRI
Number of detected cancer with Gleason Score 6	At 2 months after completing first screening round (last included biopsy procedure). At two months after completing repeat screening rounds ( year 3, 6, 9, 12 and 15).	Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm
Number of infectious complications	Questionnaire collection finalised within 2months after last biopsy procedure in study	As assessed by questionnaire within 2 month after biopsy procedure

Trial Locations

Locations (3)

C-medical Odenplan Urology; 🇸🇪 Stockholm, Sweden

Urologifocus; 🇸🇪 Stockholm, Sweden

Capio St Görans Hospital; 🇸🇪 Stockholm, Sweden