NCT07623941Recruiting
CUIMC Focal Therapy Registry
Columbia University Prostate Cancer Focal Therapy Registry
Source: ClinicalTrials.gov · Last updated 3 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 29 May 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 31 Dec 2035
- Lead sponsor
- Columbia University
- Diseases
- Prostate cancer
- NCT number
- NCT07623941
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jan 2026 to the primary completion date, 31 Dec 2035
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous urethral sling, artificial urinary sphincter, or penile prosthesis surgery
Other illness
- Any medical condition that would compromise the subject's ability to safely participate in the study
- Active urinary tract infection
- Active, uncontrolled inflammatory bowel disease
- Urinary tract or rectal fistula
- Any contraindication to MRI (such as contrast allergy, sever claustrophobia, MRI-incompatible prosthesis)
Other
- 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
- American Society of Anesthesiologists (ASA) criteria of IV or higher
- Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
Who the study is looking for
- 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
Age in the registry: 40 years to 85 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.