PSMA PET/MRI-guided targeted biopsies after a negative prostate MRI
GUidance In Prostate Cancer DEtection With 18F-PSMA-1007-PET/MRI and Targeted Biopsies (GUIDE PSMA PET/MRI)
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aarhus University Hospital Academic / other |
| Locations | 2 sites (Aarhus N, Aarhus and 1 other locations) |
| Trial ID | NCT07258056 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Aarhus N, Aarhus and 1 other locations
- Aarhus University Hospital — Aarhus N, Aarhus, Denmark (Recruiting)
- Goedstrup Hospital — Herning, Herning, Denmark (Recruiting)
Study contacts
- Study coordinator: Mads R Jochumsen, MD, Ph.D.
- Email: madsjoch@rm.dk
- Phone: +45 + 78456270
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.