CUIMC Focal Therapy Registry
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age40-85
SponsorColumbia University
About this trial
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.
Eligibility criteria
Qualifiers
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
histologically confirmed prostate adenocarcinoma from targeted biopsy cores
Disqualifiers
Any Gleason score 4+4 outside an MRI-identified region of interest
Prostatic calcifications which in the opinion of the investigator would impede delivery of the energy to tumor in patients choosing HIFU
Any medical condition that would compromise the subject's ability to safely participate in the study
American Society of Anesthesiologists (ASA) criteria of IV or higher
Trial design
Treatments tested in this trial
- Focal therapy
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov