PAE May Become Standard of Care for BPH within 3-7 Years
Interview with Dr. Riad Salem, Northwestern University, Chicago, IL
The United States Food and Drug Administration (FDA) is working collaboratively with interventional radiologists which could lead to prostatic artery embolization (PAE) becoming standard of care for treating BPH (benign prostatic hyperplasia) within the next 3-7 years, according to Dr. Riad Salem MD, MBA , who is Professor of Radiology, Medicine and Surgery, Vice-Chairman of Image-Guided Therapy, and Chief of Vascular and Interventional Radiology at Northwestern University.
"So far the approval process has gone smoothly and am optimistic that PAE may benefit many men with BPH in the coming years. The FDA is appropriately involved with investigational devices and it has provided guidelines to help us go through the process. It has been very been collaborative" said Dr. Salem.
Dr. Salem presented a talk titled "Investigational Device Exemption: Experience with Prostatic Artery Embolization" at #GEST2014. He discussed the FDA processes and perspective on this new potential indication for this type of embolization.
"PAE is not the standard of care of therapy for BPH or hypertrophy and because of that we need to investigate it properly and establish guidelines. What the FDA is concerned about is that people are starting procedures like PAE without it going through rigorous testing and investigation. We need to go through that process in order to establish it as another standard of care along with transurethral resection of the prostate (TURP) and surgery."
Dr. Salem said there is compelling evidence for performing PAE for BPH. He noted that there has been proof of concept as well as technical reviews and studies that have been reproducible. "I think PAE is the real deal and the proof of concept is clearly there. It is technically challenging, but once you go through the learning curve it can clearly be beneficial. We believe in it and we think in the next 3-7 years PAE will become part of the standard of care," said Dr. Salem.
He said there is strong clinical evidence to support the use of PAE for the treatment of lower urinary tract symptoms (LUTS) as an option that may lower morbidity and have high efficacy rates. (1)
Dr. Salem said he has learned over the years that the FDA has a certain amount of data that are required for its approval process and there are several practical pitfalls that occur when going throug this process, including the need to obtain Category B - investigational device exemption (IDE) status which will cover Medicare. He said with this category there needs to be an unexpected number of patients aged 65 and older requesting treatment with PAE.
"Respond to a rejection letter as you would a revision for a manuscript, with comments and rebuttal," Dr. Salem told clinicians attending the meeting. Dr. Salem said he and his team have had experience with 5 other IDEs. They include particle embolization for uterine artery embolization (UAE) (N=30), Y90 in Salvage Setting (N=151), Capecitabine with Y90 for Chemorefractory metastases (N=17), STOP HCC-sorafenib +/- Y90 (N=400), YES-p-sorafenib vs Y90 (N=360).
"We have experience and the process is reproducible. We have done this 5 times before and so it can be a template to some extent," said Dr. Salem.
He said there is a clear unmet medical need that can be addressed through PAE. He also noted that the simplicity of technique. However, he noted it is important to validate international groups and establish PAE for BPH through rigorous testing.
1) Golzarian, J., Antunes, A.A, Bilhim, T., et al. Prostatic Artery Embolization to Treat Lower Urinary Tract Symptoms Related to Benign Prostatic Hyperplasia and Bleeding in Patients with Prostate Cancer: Proceedings from a Multidisciplinary Research Consensus Panel. JVIR. May 2014;25:665-674.