Protons for prostate cancer: the dream versus the reality.

demonstrate the sensitivity and specificity of claims-based algorithms to detect important radiotherapy outcomes and exposures across disease sites. Second, equipment manufacturers should develop unique technology identifiers for radiotherapy devices and image guidance that would facilitate identification in registries or possibly claims data. For example, the proposed National Radiation Oncology Registry will ascertain finer details on radiotherapy delivery quality at a population level through an integrated electronic infrastructure (8). Third, investigators should explore novel, prospective CER clinical trial designs. Randomization is the most appropriate study design to minimize confounding when investigators hypothesize modest to moderate differences in outcomes between treatment exposures (as with proton therapy for prostate cancer); large-scale, pragmatic, ran-domized trials or parallel, randomized and observational cohort studies can extend the generalizability of traditional randomized studies (9). Is a randomized trial of proton therapy vs IMRT worth the costs? A rough calculation of the incremental health-care expenditures associated with replacing IMRT with proton therapy for even just one-third of the nearly 28 000 Medicare beneficiaries who received treatment in 2008 and 2009 would be at least $100 million of excess spending. The costs of a randomized trial that would compare the two radiation modalities range from $5 to $15 million. For such a scientifically important question in radiotherapy CER, a randomized trial of proton therapy vs IMRT would appear to be a good investment for patients and clinicians. The University of Pennsylvania and the Massachusetts General Hospital have partnered with other centers to conduct this randomized trial. Similar efforts, combined with important findings from Yu et al. (3), will continue to build the body of evidence for advanced radiotherapy technologies. Proton versus intensity-modulated radio-therapy for prostate cancer: patterns of care and early toxicity. et al. Intensity-modulated radiation therapy, proton therapy, or conformal radiation therapy and morbidity and disease control in localized prostate cancer. Note The study sponsors had no role in the writing of the editorial or the decision to submit it for publication. Proton therapy has generated much excitement among physicians and patients. During the period from 2006 to 2009, the number of prostate cancer patients treated with protons nearly doubled (1) and use continues to rise. There are 11 operational proton facilities in the United States, opening at a rate of more than 1 per year over the past 6 years. Why is everyone so excited? There are at least three reasons. Two are clear, and one is …