Recruiting

Observational Study

Sponsor:

Columbia University

Code:

NCT07623941

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Focal therapy

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT07623941

Start date

Jan 1, 2026

Status verified date

May, 2026

Completion date

Dec 31, 2040

Anticipated

Primary completion date

Dec 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Interventions

Focal therapy

Focal ablation of prostate cancer using IRE or HIFU

Primary outcome measure

  • Failure free survival [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

Columbia University Irving Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Izak Faiena

212-305-0114if2274@cumc.columbia.edu

Principal Investigator:

Izak Faiena, MD, MSCR

More Information

Sponsor

Columbia University

Last update posted

Jun 3, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-06-03.