| NCT ID | NCT07623941 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Columbia University |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2035-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2026-01-01 with a primary completion date of 2035-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Frequently Asked Questions
Who can join the NCT07623941 clinical trial?
This trial is open to male participants only, aged 40 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07623941 currently recruiting?
Yes, NCT07623941 is actively recruiting participants. Visit ClinicalTrials.gov or contact Columbia University to inquire about joining.
Where is the NCT07623941 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT07623941 clinical trial?
NCT07623941 is sponsored by Columbia University. The trial plans to enroll 1,000 participants.
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