High Resolution, 18F-PSMA PET-MRI Before Prostate Cancer HIFU or Radical Prostatectomy
Phase 2
Terminated
NCT04461509
| Condition | Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site |
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| Phase | Phase 2 |
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| Sponsor | Alessandro D'Agnolo |
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| Status | Terminated |
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| Enrollment | 62 participants |
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| Interventions | 18F-PSMA |
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| Start date | Apr 6, 2021 |
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| Completion date | Sep 3, 2024 |
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| Results posted | May 29, 2025 |
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Summary
This prospective trial aims to determine if enhanced prostate imaging using two novel imaging technologies (high resolution DWI and 18F-PSMA PET-MRI) will detect prostate cancers not seen on standard multiparametric prostate MRI in patients considered candidates for focal HIFU.
Primary Endpoint (HIFU): Identification of New Cancers
At time of pre-HIFU biopsy · biopsy-proven cancerous zones
| ARM 1 (HIFU) - 18F-PSMA | 85 biopsy-proven cancerous zones |
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| ARM 1 (HIFU) - 18F-PSMA | 49 biopsy-proven cancerous zones |
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Primary Endpoint (HIFU):
preoperative PET-hrMRI prior to prostatectomy, less than 3 weeks before surgery · Participants
| Arm 1 Focal High-Intensity Focused Ultrasound (HIFU) | 8 Participants |
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Open in BENITIONS
View on ClinicalTrials.gov
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