Columbia Center's Focused Prostate Cancer Treatments Registry

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry records patient, disease, and treatment details for men undergoing focal therapy with high-intensity focused ultrasound (HIFU) or irreversible electroporation (IRE) at Columbia University Irving Medical Center. No treatment is given by the registry itself, and there is no randomization. The study uses MRI-based targeting and follows patients to track surgical, oncologic, functional, and quality-of-life outcomes after focal ablation. It also investigates factors associated with successful ablation, follow-up assessment methods, and the potential role of post-treatment biopsies in confirming lesion control. Data collection will inform feasibility, effectiveness, and decision-making for focal therapy in localized prostate cancer.

Why it matters

Who can join: the full rules

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)

Where it's running

• Columbia University Irving Medical Center
  New York, New York, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.