CUIMC Focal Therapy Registry

May 29, 2026 updated by: Izak Faiena, Columbia University

Columbia University Prostate Cancer 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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective of this study is to evaluate surgical, oncologic, functional, and quality-of-life outcomes following focal treatment with high-intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) in patients with localized prostate cancer. The study will assess the feasibility and efficacy of focal prostate tissue ablation using these treatment approaches.

Multiparametric MRI will be used to identify regions of interest within the prostate and to support treatment planning and targeting. The investigators aim to further characterize outcomes after focal ablation with HIFU and IRE, including treatment-related effects, cancer control, and patient-reported quality-of-life measures.

In addition, the study will examine factors associated with ablation success, including targeting strategy and post-treatment assessment methods. Follow-up biopsy protocols will also be evaluated to determine their role in assessing treatment efficacy and confirming lesion ablation after focal therapy.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center
        • Contact:
        • Principal Investigator:
          • Izak Faiena, MD, MSCR

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with localized prostate cancer

Description

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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Failure free survival
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

December 31, 2035

Study Completion (Estimated)

December 31, 2040

Study Registration Dates

First Submitted

May 29, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 3, 2026

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAU8649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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