NCT03377881: STHLM3MR-2

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

Active, enrolled NA Last updated 26 December 2023

What this trial tests

NA trial testing MRI/Fusion biopsies in Prostate Cancer in 12,750 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

4 April 2018

Primary endpoint
10 December 2020

10 December 2030

Quick facts

Lead sponsor	Karolinska Institutet
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	12,750
Start date	4 April 2018
Primary completion	10 December 2020
Estimated completion	10 December 2030
Sites	3 locations across Sweden

Drugs / interventions tested

• MRI/Fusion biopsies
• Systematic biopsies

Conditions studied

• Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

Karolinska Institutet

Who can join

Adults 50 to 74, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. MRI-Targeted or Standard Biopsy in Prostate Cancer Screening.
   Eklund M, Jäderling F, Discacciati A, Bergman M, et al · · 2021 · cited 269× · PMID 34237810 · DOI 10.1056/nejmoa2100852
2. 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.
   Nordström T, Discacciati A, Bergman M, Clements M, et al · · 2021 · cited 134× · PMID 34391509 · DOI 10.1016/s1470-2045(21)00348-x
3. Cost-effectiveness of Prostate Cancer Screening Using Magnetic Resonance Imaging or Standard Biopsy Based on the STHLM3-MRI Study.
   Hao S, Discacciati A, Eklund M, Heintz E, et al · · 2022 · cited 33× · PMID 36355382 · DOI 10.1001/jamaoncol.2022.5252
4. Repeated Prostate Cancer Screening Using Prostate-Specific Antigen Testing and Magnetic Resonance Imaging: A Secondary Analysis of the STHLM3-MRI Randomized Clinical Trial.
   Nordström T, Annerstedt M, Glaessgen A, Carlsson S, et al · · 2024 · cited 18× · PMID 38324313 · DOI 10.1001/jamanetworkopen.2023.54577
5. Cost-Effectiveness of the Stockholm3 Test and Magnetic Resonance Imaging in Prostate Cancer Screening: A Microsimulation Study.
   Hao S, Heintz E, Östensson E, Discacciati A, et al · · 2022 · cited 16× · PMID 35094896 · DOI 10.1016/j.eururo.2021.12.021
6. Biomarker vs MRI-Enhanced Strategies for Prostate Cancer Screening: The STHLM3-MRI Randomized Clinical Trial.
   Björnebo L, Discacciati A, Falagario U, Vigneswaran HT, et al · · 2024 · cited 14× · PMID 38648061 · DOI 10.1001/jamanetworkopen.2024.7131
7. 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.
   Nordström T, Jäderling F, Carlsson S, Aly M, et al · · 2019 · cited 13× · PMID 31201191 · DOI 10.1136/bmjopen-2018-027816
8. The impact of pre-biopsy MRI and additional testing on prostate cancer screening outcomes: A rapid review.
   Tesfai A, Norori N, Harding TA, Wong YH, et al · · 2024 · cited 10× · PMID 38633829 · DOI 10.1002/bco2.321