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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard arm (One testing with PSA and standard biopsy) | Other | 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. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI/Fusion biopsies | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen | Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of detected cancer with Gleason Score 6 | Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm | 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). |
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Inclusion Criteria:
Exclusion Criteria:
• Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Nordström, MD PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C-medical Odenplan Urology | Stockholm | Sweden | ||||
| Capio St Görans Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28753850 | Background | 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. | |
| 34391509 |
| Label | URL |
|---|---|
| Study homepage | View source |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Two-step design with a first step using paired design for blood-analysis and a second step using randomisation between prostate biopsy strategy. Repeated screening using individualised screen intervals for participants randomised to the experimental (MRI) arm and without prostate cancer diagnosed.
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| Systematic biopsies | Procedure | The intervention in the control arm is traditional systematic biopsies of the prostate. |
|
| Number of performed biopsy procedures in the study arms |
Number of performed prostate biopsy procedures counted per study arm |
| 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 MRI in the study arms | Number of performed prostate MRI procedures counted per study arm | 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 infectious complications | As assessed by questionnaire within 2 month after biopsy procedure | Questionnaire collection finalised within 2months after last biopsy procedure in study |
| Distribution of MRI findings in men positive for Stockholm3 and/or PSA | 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 | 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). |
| Stockholm |
| Sweden |
| Urologifocus | Stockholm | Sweden |
| 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. |
| 34237810 | Result | 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. |
| 42330502 | Derived | Palsdottir T, Micoli C, Eklund M, Gronberg H, Jaderling F, Tilki D, Lin DW, Cooperberg MR, Eggener SE, Oeffinger KC, Nordstrom T, Vigneswaran HT. Stockholm3-Magnetic Resonance Imaging Population-Based Prostate Cancer Screening Study: Two-Year Follow-up. Ann Intern Med. 2026 Jun 23. doi: 10.7326/ANNALS-25-04753. Online ahead of print. |
| 38648061 | Derived | 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. |
| 38324313 | Derived | 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. |
| 35094896 | Derived | 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. |
| 31201191 | Derived | 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |