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Observational Study of HIFU Ablation for Prostate Cancer

This study is looking at the real-world results of High-Intensity Focused Ultrasound (HIFU) ablation for prostate cancer. It aims to understand how well HIFU works, any side effects, and how it affects urinary and sexual function over time. Researchers will collect data from men aged 40 to 95 who have prostate cancer that is contained within the prostate and choose HIFU as their treatment. The study will track changes in your Prostate-Specific Antigen (PSA) levels, and your urinary function and continence scores for up to 60 months (5 years) after the HIFU procedure. The goal is to gather long-term information to improve future patient care.

Study design
This is an observational study planning to enroll 300 men. It will follow participants who choose HIFU ablation for prostate cancer.
What's involved
You would have your PSA levels, urinary function, and urinary continence measured at several points over 60 months after your HIFU procedure.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 60 months (5 years) after their HIFU ablation procedure.

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NCT07203482

Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

Recruiting
Not specifiedAges 40–95Observational
NYU Langone Health
~300 participants
Updated 2026-07-30 on ClinicalTrials.gov

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Prostate-Specific Antigen (PSA) Levels
Measured over Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
+10 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 1 states
New York2

Study leadership

  • James Wysock, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Majlinda Tafa, MD
[email protected]
(646) 825-6338
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in Prostate-Specific Antigen (PSA) LevelsBaseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
  • Change in Urinary Function ScoreBaseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

    Urinary Function is assessed using an 8-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 41; lower scores indicate greater urinary function.

  • Change in Urinary Continence ScoreBaseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

    Urinary Continence is assessed using an 2-item questionnaire; each item is rated on a Likert scale from 0-3. The total score is the sum of responses and ranges from 0 - 6; higher scores indicate greater urinary continence.

  • Change in Sexual Function ScoreBaseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

    Sexual Function is assessed using a 6-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 0 - 29; lower scores indicate greater sexual function.

  • Change in Ejaculatory Function ScoreBaseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

    Ejaculatory Function is assessed using a 4-item questionnaire; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1 - 20; higher scores indicate greater ejaculatory function.

  • Change in Sexual Health Inventory for Men (SHIM) ScoreBaseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

    SHIM is a 5-item questionnaire assessing sexual health in men; each item is rated on a question-specific Likert scale. The total score is the sum of responses and ranges from 1-20; higher scores indicate greater sexual health.

  • Decision Regret ScoreMonth 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

    Regret toward receiving HIFU ablation focal therapy is assessed using a 5-item questionnaire. Each item is rated on a Likert scale from 1-5; the total score is the sum of responses and ranges from 5-25. Lower scores indicate less regret with the decision.

  • Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment ImagingUp to Month 60
  • Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment ImagingUp to Month 60
  • Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate BiopsyUp to Month 60
  • Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate BiopsyUp to Month 60