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Center for Global Research Data

The relative efficacy and safety of apalutamide, enzalutamide, abiraterone, and darolutamide for nonmetastatic castration-resistant prostate cancer

Lead Investigator: Lin Wang, Johns Hopkins School of Public Health, Johns Hopkins Hospital
Title of Research Proposal: The relative efficacy and safety of apalutamide, enzalutamide, abiraterone, and darolutamide for nonmetastatic castration-resistant prostate cancer
Vivli Data Request: 3762
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Until recently, nonmetastatic castration-resistant prostate cancer (nmCRPC) was managed with continued androgen-deprivation therapy (ADT) and surveillance for metastases. One-third of nmCRPC patients will develop metastasis within two years of diagnosis. Progress has been made since 2018, when four antiandrogen drugs were evaluated to be efficacious for nmCRPC. Namely, apalutamide, enzalutamide, abiraterone, and darolutamide.While all four drugs are promising for nmCRPC, it is unclear which one performs best, as there have been no studies directly or indirectly comparing all of them. Such a comparison is important for decision-making, especially when drug costs are brought into the picture. All four drugs are patent-protected except abiraterone, for which the patent expired in October 2018. The monthly costs are estimated to be $3,275 for the generic version of abiraterone as compared to $12,196 and $12,065 for apalutamide and enzalutamide, respectively. The monthly costs are provided here because these drugs are to be used until the development of metastases. The cost for darolutamide is yet to be determined as its new drug application has just been submitted to the FDA.

Considering the huge disparity in costs, it is critical to evaluate the relative efficacy and safety of these drugs and inform value-based decision-making. Are higher costs justified by better treatment effects or a better safety profile? Or is there actually no difference, making abiraterone is the most economic choice?

Requested Studies:

A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Sponsor: AstraZeneca
Study ID: NCT00626548
Sponsor ID: D4320C00015

Safety and Efficacy Study of Enzalutamide Versus Bicalutamide in Men With Prostate Cancer (STRIVE)
Data Contributor: Pfizer Inc.
Study ID: NCT01664923
Sponsor ID: NCT01664923

We will include aggregated level trial results from the following trials: 1. SPARTAN trial. NCT01946204. 2. ARN-509-001 trial. NCT01171898. 3. PROSPER trial NCT02003924. 4. IMAAGEN trial. NCT01314118. 5. ARAMIS trial. NCT02200614.
Data Contributor: I WILL BRING MY OWN
Study ID: Aggregate results data from five trials