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

NCT03377881 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12750

Last updated 2023-12-26

No results posted yet for this 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.

Conditions

Interventions

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.

PROCEDURE

Systematic biopsies

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

Sponsors & Collaborators

Principal Investigators

  • Tobias Nordström, MD PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
74 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-04
Primary Completion
2020-12-10
Completion
2030-12-10

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03377881 on ClinicalTrials.gov