Until February 2018 and the milestone ASCO GU presentations of the Phase III trials, A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN) and Safety and Efficacy Study of Enzalutamide in Patients With Nonmetastatic Castration-Resistant Prostate Cancer (PROSPER),
there did not exist a globally conducted trial demonstrating level one evidence via a randomized, prospective, blinded, placebo controlled protocol whereby an oral pharmacologic agents provided a significant delay in metastases free survival(MFS). In reviewing the AUA castration-resistant prostate cancer (CRPC) index cases and the recommendation for systemic therapeutic intervention, only index Case1, an M0 CRPC patient, lacked level one evidence for any regulatory approved medication.
The Food and Drug administration (FDA) has now approved apalutamide (Erleada®) as the first oral agent for consideration for men with M0 CRPC . Both the SPARTAN and PROSPER trials demonstrated ~ 2 year delays in metastases free survival (MFS), thus achieving the trial primary endpoint with P values<0.001; of note, clinicians will want to review each trial’s study schema, additional secondary/exploratory endpoints as well as the specific adverse events of interest. Assuredly, these landmark trials will now broaden the patient-physician shared clinical decision making discussion for advanced prostate cancer care.
The goal of the M0 CRPC Center of Excellence will be to educate the healthcare community through selected, curated content which will allow for up to date assessment from expert opinion leaders, global educational forums, ongoing trials as well as areas of possible controversy.
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