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RECRUITING
NCT07258056
NA

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

Sponsor: Mads Ryo Jochumsen

View on ClinicalTrials.gov

Summary

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.

Official title: GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-11-03

Completion Date

2038-12

Last Updated

2025-12-02

Healthy Volunteers

No

Conditions

Interventions

DIAGNOSTIC_TEST

PSMA-guided and systematic biopsies

Both PSMA-guided and systematic biopsies are performed

Locations (2)

Aarhus University Hospital

Aarhus N, Aarhus, Denmark

Goedstrup Hospital

Herning, Herning, Denmark