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Sequential Imaging of Suspicion of Prostate Cancer Reducing Overdiagnosis and Unnecessary Biopsy With Timely Diagnosis of Significant Cancer

NCT07180381 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 503

Last updated 2025-12-04

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and effectiveness of a novel diagnostic strategy for prostate cancer, in which men with a moderate risk of prostate cancer are monitored using PSA and MRI instead of immediate biopsy,.

The main questions it aims to answer are:

* Is it safe to delay biopsy, making sure that clinical significant prostate cancers are not often missed?
* Does it reduce unnecessary biopsies and overtreatment?

Conditions

Interventions

OTHER

PSA and MRI-monitoring

Men with PI-RADS 3 or 4 lesions and a PSA density ≤ 0.15 ng/mL² are actively monitored with PSA testing every six months and MRI annually, instead of undergoing immediate prostate biopsy.

Sponsors & Collaborators

  • St. Antonius Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-14
Primary Completion
2031-01-31
Completion
2031-01-31

Countries

  • Netherlands

Study Locations

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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 NCT07180381 on ClinicalTrials.gov