Prostate Cancer
Conditions
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.
Interventions
PROCEDUREMRI/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.
PROCEDURESystematic biopsies
The intervention in the control arm is traditional systematic biopsies of the prostate.
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
50 Years to 74 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of detected cancers characterized as Gleason Score ≥7 on evaluation of biopsy specimen | 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). | Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | Cancers detected by pathological evaluation of biopsy specimen collected from the respective study arm |
| 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 prostate biopsy procedures counted per study arm |
| 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 performed prostate MRI procedures counted per study arm |
| Number of infectious complications | Questionnaire collection finalised within 2months after last biopsy procedure in study | As assessed by questionnaire within 2 month after biopsy procedure |
| 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). | 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 |
Countries
Sweden
Outcome results
None listed