NCT07258056 GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies
| NCT ID | NCT07258056 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mads Ryo Jochumsen |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-11-03 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-11-03 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07258056 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07258056 currently recruiting?
Yes, NCT07258056 is actively recruiting participants. Contact the research team at madsjoch@rm.dk for enrollment information.
Where is the NCT07258056 trial being conducted?
This trial is being conducted at Aarhus N, Denmark, Herning, Denmark.
Who is sponsoring the NCT07258056 clinical trial?
NCT07258056 is sponsored by Mads Ryo Jochumsen. The trial plans to enroll 100 participants.
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