NCT07180381

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 503 (estimated)
• Sponsor: St. Antonius Hospital · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-14
• Primary completion: 2031-01-01
• Completion: 2031-01-01
• First posted: 2025-09-18
• Last updated: 2025-12-04

Locations

7 sites across 1 country: Netherlands