Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

Part of paid clinical trials in Brooklyn, New York.

Sponsor
NYU Langone Health
Study ID
NCT07203482
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 95 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 16, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2050

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NYU Langone Health - Cobble HillBrooklynNew York11201-
NYU Langone Health - Tisch HospitalNew YorkNew York10016-

Find similar trials in Brooklyn, NY

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
NYU Langone Health - Cobble Hill· Brooklyn, NYNYU Langone Health - Tisch Hospital· New York, NY

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