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This paper presents a study protocol for an effectiveness evaluation ofantiandrogenic (NAM) medications (i.e. abiraterone acetate and enzalutamide)against standard of care in patients suffering from metastatic castrateresistant prostate cancer. The study protocol takes stock in the Rubin CausalModel for observational data in using historical comparisons for the analysison three outcomes: mortality, pain and skeleton related events. We restrict theevaluation to 1,285 NAM patients with a prostate cancer diagnosis after June2012 and find the comparisons in the group of men that had a prostate cancerdiagnosis between June 2008 and June 2010. The rich registry data and the lackof NAMs as an option for the comparisons provide support for the validity ofthe design. However, while the design yields balance on the observedcovariates, one cannot discard the possibility that unobserved confounders arenot balanced. Thus, sensitivity analyses are suggested.

A study protocol for a comparative effectiveness evaluation of antiandrogenic medications against Standard of Care