Development of Research Agenda in Prostate Artery Embolization: Summary of Society of Interventional Radiology Consensus Panel.

ABSTRACT

PURPOSE: To summarize the Society of Interventional Radiology Foundation's Research Consensus Panel development of a research agenda on prostate artery embolization (PAE). MATERIALS AND METHODS: PAE for the treatment of lower urinary tract symptoms has been shown to be safe and effective in decreasing symptoms and prostate size. Lack of randomized controlled trials (RCTs) on PAE in the United States has prevented inclusion in American Urologic Association guideline recommendations for treatment of lower urinary tract symptoms resulting from benign prostatic hyperplasia. Recognizing the need for well-designed trials, the SIR Foundation funded a Research Consensus Panel to prioritize a research agenda. The panel included interventional radiologists, urologists, SIR Foundation leadership, and industry representatives. The goal of the meeting was to discuss weaknesses with current data and study design for development of US trials to report long-term outcomes data. RESULTS: Final consensus on a research design could not be made because the group was split on 3 research designs (i) RCT of PAE versus sham with crossover of the sham group. (ii) RCT of PAE versus simple prostatectomy. (iii) RCT of PAE versus holmium laser enucleation of the prostate/thulium laser enucleation of the prostate. The panel recommended a nonindustry-funded registry to obtain real-world data. CONCLUSIONS: Level 1 data are required to be included in the American Urologic Association guidelines for treatment of benign prostatic hyperplasia. Because of concerns with all 3 study designs, the panel did not reach a consensus. Further meetings are planned with the panel to select among these research designs.