RecruitingNot ApplicableNCT07258056

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 (GUIDE PSMA PET/MRI)

Sponsor

Mads Ryo Jochumsen

Enrollment

100 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a specialized type of imaging scan combining PET (using a tracer that targets prostate cancer cells) and MRI can help detect prostate cancer in men who have a high PSA density but a normal or inconclusive MRI result. The goal is to find cancer earlier and more accurately. **You may be eligible if...** - You have a PSA density (a blood marker for prostate cancer) above 0.20 - Your MRI result was normal or inconclusive (PI-RADS 1–2) or your previous targeted biopsy was negative - Your MRI was done within the last 6 months - You can read and understand Danish - Your expected remaining lifespan is greater than 10 years **You may NOT be eligible if...** - You already have a confirmed prostate cancer diagnosis - You have conditions that prevent you from having an MRI (e.g., metal implants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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