Clinical trial NCT03377881: Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
Official title: STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 12750
Sex: MALE
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen
timeFrame: 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).
Secondary outcomes:
measure: Number of detected cancer with Gleason Score 6
timeFrame: 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).
measure: Number of performed biopsy procedures in the study arms
timeFrame: 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).
measure: Number of performed MRI in the study arms
timeFrame: 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).
measure: Number of infectious complications
timeFrame: Questionnaire collection finalised within 2months after last biopsy procedure in study
measure: Distribution of MRI findings in men positive for Stockholm3 and/or PSA
timeFrame: 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).
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: C-medical Odenplan Urology
city: Stockholm
country: Sweden
facility: Capio St Görans Hospital
city: Stockholm
country: Sweden
facility: Urologifocus
Study officials:
affiliation: Karolinska Institutet
name: Tobias Nordström, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.