Outcomes after HIFU ablation for localized prostate cancer
A Single-center Observational Study of Clinical Outcomes of Clinically Localized Prostate Cancer Undergoing HIFU Therapy
See if HIFU affects cancer control and urinary and sexual function in men with localized prostate cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 40 Years to 95 Years |
| Sex | Male |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (Brooklyn, New York and 1 other locations) |
| Trial ID | NCT07203482 on ClinicalTrials.gov |
What this trial studies
This project will prospectively collect clinical and patient-reported outcome data from men who undergo focal high-intensity focused ultrasound (HIFU) ablation for localized prostate cancer at participating sites. Collected data will include treatment-related complications, oncologic outcomes (such as PSA trends and biopsy results), and urinary and sexual function measured with validated instruments over long-term follow-up. Cases performed by study sub-investigators at NYU Langone locations will be entered into a standardized database to identify predictors of complications, oncologic control, and functional outcomes. The longitudinal dataset is intended to inform future research and help clinicians counsel patients about expected outcomes after focal HIFU.
Who should consider this trial
Good fit: Men aged 40–95 with clinically localized, focal prostate cancer confined to the prostate on MRI and biopsy (typically Gleason 6 or 7) who choose focal HIFU and can provide consent are the intended participants.
Not a fit: Men with metastatic disease, men who choose other treatments, or those unwilling or unable to give consent would not be candidates and are unlikely to benefit from this data collection.
Why it matters
Potential benefit: If successful, this database could help doctors better predict complications and functional outcomes after focal HIFU, improving patient selection and counseling.
How similar studies have performed: Prior observational series and registries report promising oncologic and functional results with focal HIFU, but high-quality prospective long-term data using validated outcome instruments remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males, ages 40-95 * Evidence of focal prostate cancer confined to the prostate based on MRI imaging and prostate biopsy * Patients with clinically localized prostate cancer (no evidence for or concern for metastatic spread of cancer outside of the prostate) that select focal HIFU prostate ablation as their treatment option will be offered inclusion into this prospective data collection research database. * Patients who have early (Gleason 6 or 7), low grade cancer that is confined to the prostate. * Willing and able to provide consent. Exclusion Criteria: * Patients that are not diagnosed with prostate cancer. * Patients that are diagnosed with clinically localized prostate cancer, but select other tratment options as their desired treatment. * Patients that are not willing or are not able to give consent.
Where this trial is running
Brooklyn, New York and 1 other locations
- NYU Langone Health - Cobble Hill — Brooklyn, New York, United States (Recruiting)
- NYU Langone Health - Tisch Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: James Wysock, MD — NYU Langone Health
- Study coordinator: Majlinda Tafa, MD
- Email: Majlinda.Tafa@nyulangone.org
- Phone: (646) 825-6338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.