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Taking people in DenmarkNo phase

PSMA PET/MRI-guided biopsies to find prostate cancer after a negative MRI scan

Compares scan-guided and standard biopsies for prostate cancer in men with negative MRI.

Plain-language title generated from the registry record
Registry title: GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies

Key facts

Where
Aarhus N and Herning, DenmarkSee the 2 sites

Where in Denmark

  • Aarhus University HospitalAarhus N, DenmarkTaking people
  • Goedstrup HospitalHerning, DenmarkTaking people

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Trial details

Who runs it
Mads Ryo Jochumsen
Trial code
NCT07258056
Record updated
2 December 2025
Original description
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:Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Known prostate cancer; MRI contraindications.

ClinicalTrials.gov NCT07258056