Detecting prostate recurrence after HIFU with PSMA PET/MRI
Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
This project will test whether PSMA PET/MRI finds prostate cancer recurrence better than standard MRI in men treated with focal HIFU therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 95 Years |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07184970 on ClinicalTrials.gov |
What this trial studies
This observational study at NYU Langone will compare PSMA PET/MRI with standard multiparametric MRI to detect focal therapy failure one year after high-intensity focused ultrasound (HIFU). Eligible men will undergo scheduled imaging and follow-up, with targeted biopsies as needed to confirm suspected recurrence. The main outcome is sensitivity of each imaging method for identifying recurrent or persistent cancer, using biopsy or clinical follow-up as reference standards. All scans are performed at the study site and investigators will analyze concordance and missed lesions between modalities.
Who should consider this trial
Good fit: Men aged 40–95 with biopsy-proven, unifocal localized prostate cancer Grade Group ≥2 who are undergoing focal HIFU, have PSA <20, no metastatic disease, and can tolerate MRI and PET procedures are ideal candidates.
Not a fit: Patients with metastatic disease, multifocal prostate cancer, allergy to the PET tracer or gadolinium, or who cannot tolerate MRI are unlikely to benefit from this imaging comparison.
Why it matters
Potential benefit: If successful, this approach could catch recurrent prostate cancer earlier or more accurately after HIFU, helping guide targeted retreatment.
How similar studies have performed: PSMA PET has improved detection in post-treatment biochemical recurrence and PET/MRI shows promising sensitivity, but its specific performance for detecting focal HIFU failure is less well established and remains under study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male patients 40-95 years of age with biopsy-confirmed localized prostate cancer. * Grade Group ≥2 (Gleason score 3+4 or higher). * Unifocal disease visible on mpMRI. * Patients undergoing HIFU as part of their standard of care * PSA \<20 ng/mL. * No metastatic disease on PSMA PET/CT * Willingness to comply with follow-up protocols (PSA testing, imaging, biopsies). Exclusion Criteria: * Evidence of metastatic disease on PSMA PET/CT. * Allergy to POSLUMA or gadolinium. * Inability to tolerate MRI due to claustrophobia or posture/back-hip issues.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Wei Phin Tan — NYU Langone Health
- Study coordinator: Majlinda Tafa
- Email: Majlinda.Tafa@nyulangone.org
- Phone: (646) 825-6338
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.