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

Prostate Cancer Clinical Trial

— STHLM3MR-2  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03377881
• Other study ID #: STHLM3MR-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2018
• Est. completion date: December 10, 2030

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12750
• Est. completion date: December 10, 2030
• Est. primary completion date: December 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	C-medical Odenplan Urology	Stockholm
Sweden	Capio St Görans Hospital	Stockholm
Sweden	Urologifocus	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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 — View 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 ( — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).
Secondary	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
Secondary	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).

External Links

•   Study homepage