GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

The goal of this clinical study is to test the performance of PSMA PET/MRI-guided biopsies against systematic biopsies in men with negative MRI scan (PI-RADS 1-2) of the prostate with continuous suspicion of clinically significant prostate cancer (csPCa) due to PSAd \> 0.20. The main questions it aims to answer are: Can biopsies safely be avoided at PRIMARY score 1-2 without missing csPCa? Does targeted PSMA PET/MRI-guided biopsies have a higher detection rate of csPCa compared to systematic biopsies? Participants will undergo both transperineal MRI/ultrasound fusion target biopsies from PRIMARY score 3-5 lesions on PSMA PET and systematic biopsies irrespective of the PRIMARY-lesion.

Key facts

Study ID

NCT07258056

Run by

Mads Ryo Jochumsen

People needed

100

Starts

2025-11-03

Expected to finish

2038-12-01

Last updated by the study team

2025-12-02

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• PSAdensity > 0.20
• Negative MRI (PI-RADS 1-2) or negative biopsy from MRI-target
• MRI within 6 months
• Read and understand danish
• Expected remaining lifetime > 10 years

You may not qualify if…

• Known prostate cancer
• MRI contraindications

Where it is running

• Aarhus University Hospital — Aarhus N, Aarhus, Denmark (enrolling)
• Goedstrup Hospital — Herning, Herning, Denmark (enrolling)

Full record on ClinicalTrials.gov

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