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Clinical trial Recruiting at 2 sites Interventional Ages 18 and up Men only

PSMA PET/MRI-guided targeted biopsies after a negative prostate MRI

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

Run by Aarhus University Hospital · NCT07258056 · Data updated 2026-11-12

This will test whether PSMA PET/MRI-targeted biopsies can better find significant prostate cancer or allow some men with a negative MRI to avoid biopsy when PSA density is elevated.

Quick facts

Study typeInterventional
Ages18 Years and up
SexMen only
Enrollment100 (estimated)
SponsorAarhus University Hospital
Academic / other
Locations2 sites (Aarhus N, Aarhus and 1 other locations)
StatusRecruiting
StartedNovember 3, 2025
Main results expectedDecember 2028
Study endsDecember 2038
Registry record updatedDecember 2, 2025
Trial IDNCT07258056 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with continuous suspicion of prostate cancer despite a negative prostate MRI (PI-RADS 1-2) or negative MRI-target biopsy, PSA density >0.20, MRI within six months, able to read Danish, and with expected remaining lifetime >10 years.

Probably not a fit

Men with known prostate cancer, with contraindications to MRI, non-Danish speakers, or with low PSA density (<0.20) are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Men with ongoing suspicion of clinically significant prostate cancer despite a negative MRI (PI-RADS 1-2) and PSA density >0.20 receive 18F-PSMA-1007 PET/MRI. Participants undergo both PSMA PET/MRI-guided transperineal MRI/ultrasound fusion targeted biopsies of PRIMARY score 3-5 PET lesions and systematic biopsies regardless of PET findings. The trial compares detection rates of clinically significant prostate cancer between the targeted and systematic approaches and examines whether biopsies can be safely deferred in men with PRIMARY score 1-2. Imaging must be recent (MRI within 6 months) and participants need to meet language and life-expectancy criteria.

Why it matters

Potential benefit: If successful, this approach could reduce unnecessary biopsies for some men and improve detection of clinically significant prostate cancer in others.

How similar studies have gone: Prior work using PSMA PET for lesion detection has shown promising results in improving targeted biopsy yield, but the exact PET/MRI-guided biopsy approach in MRI-negative men is still being established.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Aarhus University Hospital
    Aarhus N, Aarhus, Denmark     Recruiting
  • Goedstrup Hospital
    Herning, Herning, Denmark     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.