Recruiting

HIFU

Sponsor:

NYU Langone Health

Code:

NCT07203482

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT07203482

Start date

May 16, 2024

Status verified date

Jul, 2026

Completion date

Dec 31, 2050

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Prostate Cancer Patients Scheduled for HIFU Procedure

Participants will be actively followed up for the first 3 years. After that once a year for life, unless they withdraw from the study or no longer seek standard of care at NYU Langone Health.

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Decision Regret Score [ Time Frame: Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, Month 48, Month 60 ]
  • Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Imaging [ Time Frame: Up to Month 60 ]
  • Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Imaging [ Time Frame: Up to Month 60 ]
  • Number of Participants with Persistence or Recurrence of Cancer within the Treatment Zone on Post-Treatment Prostate Biopsy [ Time Frame: Up to Month 60 ]
  • Number of Participants with New Lesions in the Non-Treated Prostate on Post-Treatment Prostate Biopsy [ Time Frame: Up to Month 60 ]

Central Contacts and Locations

Central contacts

Majlinda Tafa, MD

(646) 825-6338Majlinda.Tafa@nyulangone.org

James Wysock, MD

(646) 825-6366James.Wysock@nyulangone.org

Locations

NYU Langone Health - Cobble Hill

Recruiting

Brooklyn, New York, United States, 11201

NYU Langone Health - Tisch Hospital

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-30.