CUIMC Focal Therapy Registry
Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. No treatment will be given, no ra
| Condition(s) | Prostate Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Patients undergoing high intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) for prostate cancer will be invited to consent to have their data collected in a detailed comprehensive system to record and store patient, disease, and treatment-related characteristics. No treatment will be given, no randomization will occur, and each patient seen and treated for prostate cancer specifically with HIFU and IRE method in the Department of Urology division of Urologic Oncology within Columbia University Irving Medical Center will be eligible to be enrolled in the database. |
| Who can participate | Inclusion Criteria: * Organ-confined prostate adenocarcinoma diagnosed by MRI/ultrasound fusion biopsy within a multiparametric MRI derived region of interest * Clinical stage T2cN0M0 (radiological T3a is permitted) * Multi-parametric MRI at New York-Presbyterian hospital (NYPH) within the past 6 months demonstrating region of interest suspicion level 2 by the Prostate Imaging Reporting and Data System version 2.0 scoring criteria * Transrectal or transperineal ultrasound-guided biopsy with 10 template biopsy cores and 2 MRI-ultrasound fusion targeted biopsy cores from the above MRI-derived region of interest demonstrating: 1. histologically confirmed prostate adenocarcinoma from targeted biopsy cores 2. unilateral Gleason score 4+3 prostate adenocarcinoma * Age 40 to 85 years of age * Sub |
| Ages | 40 Years to 85 Years |
| Sex | Male |
| Lead sponsor | Columbia University |
| Locations | New York, New York, United States |
| Start date | 2026-01-01 |
| NCT ID | NCT07623941 |
| Official listing | https://clinicaltrials.gov/study/NCT07623941 |