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  1. Advancing Regulatory Science

Assessment of Patient Tolerance for Risk with High Intensity Focused Ultrasound (HIFU) that Destroys Prostate Tissue

CERSI Collaborators: M. Minhaj Siddiqui, MD, University of Maryland, Baltimore PI

FDA Collaborators: Charles Viviano, MD, PhD – FDA Lead; David Gebben, PhD; Olufemi Babalola, MSc, MHS, CDRH/FDA

Project Start Date to End Date: June 26, 2020-January 15, 2022

Regulatory Science Challenge

Prostate cancer is the most commonly diagnosed solid (as opposed to hollow or liquid) organ cancer and the second leading cause of cancer death in American men. The usual treatment for localized prostate cancer includes surgery (radical prostatectomy) or radiation. Both treatments have well-known long-term cancer outcomes and side effects. The most common side effects include sexual issues such as erectile dysfunction and urinary issues such as leakage (urinary incontinence). Complaints about side effects have led to calls for newer methods of prostate cancer treatment. High intensity focused ultrasound (HIFU) is a tool that destroys (ablates) prostate tissue. It is minimally invasive and has a lower number of bad side effects. The side effects of HIFU treatment are well-known, but few data exist on the cancer outcomes in the U.S. population.

Project Description and Goals

Different treatment options exist for patients living with prostate cancer, thus they are able to have a choice based on their perspective and preference. The goal of this research study is to assess patients’ perspectives on the benefits and risks associated with HIFU. Eligible prostate cancer patients were identified and recruited from the University of Maryland Medical Center and surveyed about their opinions on prostate ablation options. The survey tool was developed by the FDA research team based on a literature review, interviews with prostate cancer patients, and clinical and regulatory knowledge of HIFU. The information obtained from this work with patients may help inform the FDA’s decision making for new prostate ablation devices.

Research Outcomes/Results

Two hundred and twenty-three patients with a mean age of 65 years completed the survey. These patients preferred a higher chance of good biopsy outcomes, and a lower chance of erectile dysfunction caused by the treatment and urinary incontinence after treatment. The patients stated in the survey that they are willing to accept:

  • a 15.1%-point increase in erectile dysfunction caused by the treatment to achieve a 10%-point increase in a good biopsy outcome after HIFU ablation, and
  • an 8.5%-point increase in urinary incontinence for a 10%-point increase in a good biopsy.

Also, further analysis revealed that patients who thought their cancer was more aggressive were more willing to tolerate urinary incontinence. Younger men were willing to tolerate less erectile dysfunction risk than older men. Respondents with a greater than college level of education were less willing to tolerate erectile dysfunction or urinary incontinence.

Research Impacts

Incorporating patient preference information into decisions that FDA makes about regulating devices is one of the major goals of FDA’s Center for Devices and Radiological Health (CDRH). Study findings show that patients prefer specific outcomes related to prostate ablation therapies like HIFU. The study results may help inform the design and regulation of current and future prostate tissue ablation devices by providing information about outcomes that patients most desire.


Manuscript is under review at FDA and will be submitted for peer review and hopefully publication thereafter.

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