PAE May Become Standard of Care for BPH within 3-7 Years

by Global Embolization
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Global Embolization Interviews Dr. Riad Salem.

The United States Food and Drug Administration (FDA) is working collaboratively with interventional radiologists and it could lead to prostatic artery embolization (PAE) becoming part of standard of care for treating BPH (benign prostatic hyperplasia) within in the next 3- 7 years, according to Riad Salem, MD, MBA , who is Professor of Radiology, Medicine and Surgery Vice-Chairman, Image-Guided Therapy Chief, Vascular and Interventional Radiology at Northwestern University, Chicago, Illinois. He said so far the approval process was going smoothly and he is 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 entitled, "Investigational Device Exemption: Experience with Prostatic Artery Embolization" at GEST 2014 (Global Embolization Symposium and Technologies, May 1-4). 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 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 LUTS (lower urinary tract symptoms) as an option that may lower morbidity and have high efficacy rates. (1) (Jafar Golzarian, Alberto A. Antunes, Tiago Bilhim 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 2014.Issue: Vol 25; No. 5; May 2014; Pages 665-674.)

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. He said there are several practical pitfalls that occur when going through this process, including the need to obtain Category B IDE (investigational device exemptions) 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 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.


References:

1) Jafar Golzarian, Alberto A. Antunes, Tiago Bilhim 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 2014.Issue: Vol 25; No. 5; May 2014; Pages 665-674.

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