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

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

Recruiting
18 years and older
Male
Phase N/A
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Overview

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.

Eligibility

Inclusion Criteria:

  • 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 Criteria:

  • Known prostate cancer
  • MRI contraindications

Study details
    Prostate Cancer

NCT07258056

Mads Ryo Jochumsen

31 January 2026

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