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

NCT03377881 | Active Not Recruiting

• 1 other identifier: STHLM3MR-2
• Study Type: interventional
• Target: 12,750
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Number of detected cancer with Gleason Score 6

  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

  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

  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

  Questionnaire collection finalised within 2months after last biopsy procedure in study

• Distribution of MRI findings in men positive for Stockholm3 and/or PSA

  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).

Study Arms (2)

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.

Procedure: Systematic biopsies

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.

Procedure: MRI/Fusion biopsies

Interventions

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.

STHLM3+MRI/Fusion including repeat screening.

Systematic biopsies PROCEDURE

The intervention in the control arm is traditional systematic biopsies of the prostate.

Standard arm (One testing with PSA and standard biopsy)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Permanent postal address in Stockholm

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (3)

C-medical Odenplan Urology

Stockholm, Sweden

Location

Capio St Görans Hospital

Stockholm, Sweden

Location

Urologifocus

Stockholm, Sweden

Location

Related Publications (7)

• 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.

  PMID: 28753850 BACKGROUND

• 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.

  PMID: 34391509 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.

  PMID: 34237810 RESULT

• 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.

  PMID: 38648061 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.

  PMID: 38324313 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.

  PMID: 35094896 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.

  PMID: 31201191 DERIVED

Related Links

• Study homepage

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Tobias Nordström, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist PhD Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 19, 2017
• Study Start: April 4, 2018
• Primary Completion: December 10, 2020
• Study Completion (Estimated): December 10, 2030
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)