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

RECRUITINGN/ASponsored by Mads Ryo Jochumsen
Actively Recruiting
PhaseN/A
SponsorMads Ryo Jochumsen
Started2025-11-03
Est. completion2028-12
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07258056

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.

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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

Conditions2

CancerProstate Cancer

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