CERSI P.I. and Collaborator: Mohummad Minhaj Siddiqui, MD UMB School of Medicine
FDA SME and Collaborator: Charles Viviano, MD, Ph.D. CDRH, FDA
Regulatory Science Challenge
Prostate cancer is the most commonly diagnosed solid organ cancer and the second leading cause of cancer death in American men. Conventional treatment for localized prostate cancer includes surgery (radical prostatectomy) or radiation. Both treatments have well known long-term cancer outcomes and side effect profiles. The most common side effects include sexual issues such as erectile dysfunction and urinary issues such as leakage. Dissatisfaction with side effect profiles has 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 an attractive side effect profile. The side effect profile is well-known, but there are few data on the cancer effectiveness in the U.S. population.
Project Description and Goals
Patients living with prostate cancer have a unique perspective that informs choice about medical care. The goal of this research study is to assess patients’ perspectives on the benefits and risks associated with HIFU. Eligible prostate cancer patients will be identified and recruited from the University of Maryland Medical Center and surveyed regarding their understanding and opinions on prostate cancer management options. The survey tool was developed by the FDA research team based on literature review, interviews and publicly available data submitted to the FDA. The information obtained from this partnership with patients may help inform the FDA’s decision making for new prostate ablation devices.