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Clinical Trials in Sweden / NCT03377881
Active, not recruiting Not applicable

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

NCT03377881 · tracked via the Priya Life Science Sweden tracker
Sponsor
Karolinska Institutet
Phase
Not applicable
Started
2018-04-04
Last updated
2023-12-26

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

MRI/Fusion biopsiesSystematic biopsies

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.

Study 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.

Eligibility

Sex
MALE
Min age
50 Years
Max age
74 Years
Healthy volunteers
Accepted
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 outcome measure(s)

  • 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

Trial sites (3)

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

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Other trials for the same condition

Personalized Radiotherapy for Biochemical Recurrence of Prostate Cancer After Prostatectomy. Recruiting
Artificial Intelligence Supporting CAncer Patients Across Europe - the ASCAPE Project Active, not recruiting
SPCG17: Prostate Cancer Active Surveillance Trigger Trial Active, not recruiting
Prostate Cancer IRE Study (PRIS) Active, not recruiting
International Registry for Men With Advanced Prostate Cancer (IRONMAN) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03377881 on ClinicalTrials.gov ↗ ← All trials in Sweden