Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
NCT ID: NCT03377881
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
12750 participants
INTERVENTIONAL
2018-04-04
2030-12-10
Brief Summary
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The study includes individualised repeat invitations for re-screening to participants not diagnosed with prostate cancer.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Standard arm (One testing with PSA and standard biopsy)
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.
Systematic biopsies
The intervention in the control arm is traditional systematic biopsies of the prostate.
STHLM3+MRI/Fusion including repeat screening.
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.
MRI/Fusion biopsies
The intervention in the experimental arm is an MRI with targeted biopsies using fusion technique to prostate lesions. Repeat screening is offered after 2-6 years on an individualised basis.
Interventions
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MRI/Fusion biopsies
The intervention in the experimental arm is an MRI with targeted biopsies using fusion technique to prostate lesions. Repeat screening is offered after 2-6 years on an individualised basis.
Systematic biopsies
The intervention in the control arm is traditional systematic biopsies of the prostate.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Contraindications for magnetic resonance imaging (MRI) eg pacemaker, magnetic cerebral clips, cochlear implants or severe claustrophobia.
50 Years
74 Years
MALE
Yes
Sponsors
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Karolinska Institutet
OTHER
Responsible Party
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Tobias Nordström
Urologist PhD Principal Investigator
Principal Investigators
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Tobias Nordström, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Karolinska Institutet
Locations
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C-medical Odenplan Urology
Stockholm, , Sweden
Capio St Görans Hospital
Stockholm, , Sweden
Urologifocus
Stockholm, , Sweden
Countries
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References
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Nordstrom T, Picker W, Aly M, Jaderling F, Adolfsson J, Strom P, Haug ES, Eklund M, Carlsson S, Gronberg H. Detection of Prostate Cancer Using a Multistep Approach with Prostate-specific Antigen, the Stockholm 3 Test, and Targeted Biopsies: The STHLM3 MRI Project. Eur Urol Focus. 2017 Dec;3(6):526-528. doi: 10.1016/j.euf.2017.01.014. Epub 2017 Mar 28.
Nordstrom T, Discacciati A, Bergman M, Clements M, Aly M, Annerstedt M, Glaessgen A, Carlsson S, Jaderling F, Eklund M, Gronberg H; STHLM3 study group. Prostate cancer screening using a combination of risk-prediction, MRI, and targeted prostate biopsies (STHLM3-MRI): a prospective, population-based, randomised, open-label, non-inferiority trial. Lancet Oncol. 2021 Sep;22(9):1240-1249. doi: 10.1016/S1470-2045(21)00348-X. Epub 2021 Aug 13.
Eklund M, Jaderling F, Discacciati A, Bergman M, Annerstedt M, Aly M, Glaessgen A, Carlsson S, Gronberg H, Nordstrom T; STHLM3 consortium. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening. N Engl J Med. 2021 Sep 2;385(10):908-920. doi: 10.1056/NEJMoa2100852. Epub 2021 Jul 9.
Bjornebo L, Discacciati A, Falagario U, Vigneswaran HT, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Lantz A. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Apr 1;7(4):e247131. doi: 10.1001/jamanetworkopen.2024.7131.
Nordstrom T, Annerstedt M, Glaessgen A, Carlsson S, Clements M, Abbadi A, Gronberg H, Jaderling F, Eklund M, Discacciati A. Repeated Prostate Cancer Screening Using Prostate-Specific Antigen Testing and Magnetic Resonance Imaging: A Secondary Analysis of the STHLM3-MRI Randomized Clinical Trial. JAMA Netw Open. 2024 Feb 5;7(2):e2354577. doi: 10.1001/jamanetworkopen.2023.54577.
Hao S, Heintz E, Ostensson E, Discacciati A, Jaderling F, Gronberg H, Eklund M, Nordstrom T, Clements MS. Cost-Effectiveness of the Stockholm3 Test and Magnetic Resonance Imaging in Prostate Cancer Screening: A Microsimulation Study. Eur Urol. 2022 Jul;82(1):12-19. doi: 10.1016/j.eururo.2021.12.021. Epub 2022 Jan 31.
Nordstrom T, Jaderling F, Carlsson S, Aly M, Gronberg H, Eklund M. Does a novel diagnostic pathway including blood-based risk prediction and MRI-targeted biopsies outperform prostate cancer screening using prostate-specific antigen and systematic prostate biopsies? - protocol of the randomised study STHLM3MRI. BMJ Open. 2019 Jun 14;9(6):e027816. doi: 10.1136/bmjopen-2018-027816.
Related Links
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Study homepage
Other Identifiers
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STHLM3MR-2
Identifier Type: -
Identifier Source: org_study_id