NCT07623941 · Columbia University
CUIMC Focal Therapy Registry
What this study is about
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.
View original scientific description
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.
Interventions
PROCEDURE
Focal therapy
Focal ablation of prostate cancer using IRE or HIFU
Primary outcome measures
Failure free survival
Time frame: 10 years
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- histologically confirmed prostate adenocarcinoma from targeted biopsy cores
- unilateral Gleason score 4+3 prostate adenocarcinoma
- Age 40 to 85 years of age
- Subjects choose to undergo focal therapy and decline alternative treatment (such as active surveillance, radical prostatectomy, radiation therapy, cryosurgery or hormone therapy)
- Signed informed consent
Exclusion criteria
- 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
- Active urinary tract infection
- Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
- Active, uncontrolled inflammatory bowel disease
- Urinary tract or rectal fistula
- Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery
- Any contraindication to MRI (such as contrast allergy, sever claustrophobia, MRI-incompatible prosthesis)
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations