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Clinical Outcomes in Prostate Cancer Patients Undergoing HIFU Ablation

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 95 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects information over time from men with prostate cancer who choose HIFU, a treatment that uses focused sound waves to destroy cancer tissue. It tracks treatment problems, cancer control, and bladder and sexual function. It is for men ages 40–95 with early cancer that has not spread outside the prostate.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men ages 40–95.
  • MRI scans and a biopsy (a tissue sample) show cancer in a limited area within the prostate.
  • No signs of or concern about cancer spreading outside the prostate.
  • Early, low-grade prostate cancer with a Gleason score of 6 or 7, a rating based on how cancer cells look.
  • Choose focused HIFU treatment for prostate cancer with a doctor taking part in the study.
  • Willing and able to give consent to join.

Who can't join

  • Do not have a prostate cancer diagnosis.
  • Have cancer limited to the prostate but choose a treatment other than HIFU.
  • Not willing or not able to give consent.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

NY