Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Men with Prostate Cancer
- description
- 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.
Primary outcomes (2)
- measure
- Sensitivity of PSMA PET/MRI
- timeFrame
- Month 12
- description
- 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.
- measure
- Oncologic Control
- timeFrame
- Month 12
- description
- Oncologic control at 12 months, defined as the absence of cancer, determined by the scheduled biopsy at 12 months.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available