Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies (STHLM3MR-2)

STHLM3 MR Phase 2: A New Diagnostic Chain for Prostate Cancer Detection Using the Stockholm3 Test and MR/Fusion Biopsies

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: Systematic biopsies; Procedure: MRI/Fusion biopsies

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 Type: Interventional
• Enrollment (Actual): 12750
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Capio St Görans Hospital
  • Stockholm, Sweden
    • C-medical Odenplan Urology
  • Stockholm, Sweden
    • Urologifocus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Procedure: Systematic biopsies; The intervention in the control arm is traditional systematic biopsies of the prostate.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).
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).
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).

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Investigators: Principal Investigator: Tobias Nordström, MD PhD, Karolinska Institutet

Publications and helpful links

General Publications

• 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, 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.
• 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.

Helpful Links

• Study homepage

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2018
• Primary Completion (Actual): December 10, 2020
• Study Completion (Estimated): December 10, 2030

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STHLM3MR-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No