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Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in Men With Suspected Prostate Cancer

NCT07422597 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1016

Last updated 2026-03-16

No results posted yet for this study

Summary

Thousands of men take a PSA test to investigate whether they have prostate cancer every year. For the vast majority, the test is normal and further investigations are not necessary. In others, the test is sufficiently elevated that men are referred for further investigations. Most men with an elevated PSA are offered an MRI examination of the prostate gland, and for some, a tissue sample of the prostate is also recommended if the suspicion of cancer is high enough. Although this comprehensive investigation reveals most clinically significant , or dangerous cases of cancer, many indolent, or "harmless" cancer cases are also detected, which would not have caused the man any harm during his lifetime (approximately 20% of all prostate cancer diagnoses diagnosed in current clinical practive). Cancer treatment is not recommended for such cases, but for many men, the diagnosis and subsequent follow-up can cause him and his family anxity and concern. In addition, prostate biopsies are unpleasant for the patient and the investigation process is resource-intensive for both the man and the health care service.

Risk stratification uses machine learning methods to better identify the men who require further investigations with MRI and tissue samples. In this project, the investigators investigate whether the best risk stratification tools are non-inferior in detecting clinically significant prostate cancer compared to current practice, and whether they lead to fewer tissue samples, MRI scans, less health anxiety, and better cost-effectiveness.

Conditions

Interventions

DEVICE

European Study of screening for prostate cancer risk calculator

The ERSPC RCs are the currently best known and most utilised multivariable PCa risk stratification tools. All participating men undergo risk stratification by ERSPC RCs to determine need for MRI and for biopsy.

Sponsors & Collaborators

  • Norwegian Cancer Society

    collaborator OTHER

  • Norwegian University of Science and Technology

    lead OTHER

Principal Investigators

  • Petter Davik, MD, PhD · Norwegian University of Science and Technology (NTNU)

  • Magnus Steigedal, PhD · Norwegian University of Science and Technology, Head of Department (IKOM)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2027-12-31
Completion
2029-12-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

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 NCT07422597 on ClinicalTrials.gov