Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT07203482
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-16
• Status Verified: 2025-09
• Study First Submitted: 2025-09-23
• Study First Submitted QC: 2025-09-23
• Last Update Submitted: 2025-09-23
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Primary Completion: 2030-12-31
• Study Completion: 2050-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 300

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Prostate-Specific Antigen (PSA) Levels	Baseline (pre-HIFU ablation procedure), Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60
Change in Urinary Function Score	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.
Change in Urinary Continence Score	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.
Change in Sexual Function Score	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.
Change in Ejaculatory Function Score	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.
Change in Sexual Health Inventory for Men (SHIM) Score	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.
Decision Regret Score	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.
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging	Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging	Up to Month 60
Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy	Up to Month 60
Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy	Up to Month 60

Trial Locations

Locations (2)

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

NYU Langone Health - Tisch Hospital; 🇺🇸 New York, New York, United States