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NCT Number: NCT07203482

Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

Many reports of clinical outcomes following treatment of localized prostate cancer suffer from lack of prospective long-term data using objective and validated outcome instruments. The purpose of this research database is to prospectively collect data to assess treatment related complications, oncologic outcomes and urinary/sexual function, and identify predictors of complications, oncological control and functional outcomes after Hhigh-intensity focused ultrasound (HIFU) ablation of prostate cancer with the intent to guide further research and improve patient care. We will include subjects who will have a HIFU procedure performed from all Sub-Investigators included in the study.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–95 year

Sex eligibility

Male

Study type

Observational

Primary location

NYU Langone Health - Cobble Hill, Brooklyn, New York, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change in Prostate-Specific Antigen (PSA) Levels

    Time frame: Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60

  2. Change in Urinary Function Score

    Time frame: Baseline (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.

  3. Change in Urinary Continence Score

    Time frame: Baseline (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.

  4. Change in Sexual Function Score

    Time frame: Baseline (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.

  5. Change in Ejaculatory Function Score

    Time frame: Baseline (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.

  6. Change in Sexual Health Inventory for Men (SHIM) Score

    Time frame: Baseline (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.

  7. Decision Regret Score

    Time frame: Month 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.

  8. Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging

    Time frame: Up to Month 60

  9. Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging

    Time frame: Up to Month 60

  10. Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy

    Time frame: Up to Month 60

  11. Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy

    Time frame: Up to Month 60

Study contacts

Contact information is provided by the study sponsor or research team.

James Wysock, MD

CONTACT

[email protected]

(646) 825-6366

Majlinda Tafa, MD

CONTACT

[email protected]

(646) 825-6338

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Single-center Observational Study of Clinical Outcomes of Clinically Localized Prostate Cancer Undergoing HIFU Therapy

Important dates

Study start
2024
Primary completion
2030
Study completion
2050
First posted
Oct 2, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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