NCT07184970 PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
| NCT ID | NCT07184970 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-08 |
| Primary Completion | 2027-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-10-08 with a primary completion date of 2027-10-01.
⚠ 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 purpose of this study is to compare the sensitivity of PSMA PET/MRI and standard MRI in detecting focal therapy failure in the prostate one year after High-Intensity Focused Ultrasound (HIFU) treatment. Specifically, the study aims to evaluate whether PSMA PET/MRI offers a higher sensitivity than MRI alone for identifying recurrence or failure in patients undergoing focal therapy.
Eligibility 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.
Contact & Investigator
Wei Phin Tan
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT07184970 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 95 Years, 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 NCT07184970 currently recruiting?
Yes, NCT07184970 is actively recruiting participants. Contact the research team at Majlinda.Tafa@nyulangone.org for enrollment information.
Where is the NCT07184970 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07184970 clinical trial?
NCT07184970 is sponsored by NYU Langone Health. The principal investigator is Wei Phin Tan at NYU Langone Health. The trial plans to enroll 60 participants.
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