PRISM Study: Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
Prostate Recurrence Detection Using Imaging With PSMA PET/MRI Post-high Intensity Focused Ultrasound
1 other identifier
observational
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2025
CompletedFirst Posted
Study publicly available on registry
September 22, 2025
CompletedStudy Start
First participant enrolled
October 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
October 10, 2025
October 1, 2025
2 years
September 15, 2025
October 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Sensitivity of PSMA PET/MRI
Sensitivity of PSMA PET/MRI for detecting clinically significant prostate cancer at 12 months post HIFU, defined as the portion of patients with clinically significant cancer on the 12-month biopsy (reference standard) who had a positive PSMA PET/MRI.
Month 12
Oncologic Control
Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.
Month 12
Secondary Outcomes (3)
Portion of patients achieving a PSA reduction greater than 50%
Month 3, Month 6, Month 12
Change in IPSS (International Prostate Symptom Score)
Baseline, Month 12
Change in SHIM (Sexual Health Inventory for Men) Score
Baseline, Month 12
Study Arms (1)
Men with Prostate Cancer
Patients undergoing High-Intensity Focused Ultrasound (HIFU) for focal therapy of prostate cancer. Participants will be followed for one-year post-treatment, with regular monitoring through various clinical assessments.
Eligibility Criteria
Only male patients will be included in this study. The expected age range will be 40-95. There is no enrollment restrictions based upon race or ethnic origin.
You may qualify if:
- 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).
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Langone Health
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Phin Tan
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2025
First Posted
September 22, 2025
Study Start
October 8, 2025
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
- Access Criteria
- The investigator who proposed to use the data will be granted access upon reasonable request. Requests should be directed to weiphin.tan@nyulangone.org. To gain access, data requestors will need to sign a data access agreement. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's DSSB.
The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: weiphin.tan@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.