Outcomes after HIFU ablation for localized prostate cancer

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 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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.