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CUIMC Focal Therapy Registry

Columbia University Prostate Cancer Focal Therapy Registry

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 85 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
  • "Multiparametric MRI will be used to identify regions of interest within the prostate and to support treatment planning and targeting."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (1)

NY