Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

NYU Langone Health

Status: Enrolling

Conditions: Prostate Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT07203482

23-01458

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 40 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Prostate Cancer Patients Scheduled for HIFU Procedure

Description:

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.