Study Phase 3

A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Trial Information

Generic NameApalutamideProduct NameERLEADA®Therapeutic AreaEnrollment1052% FemaleN/A% White68.3%
Product ClassNonsteroidal antiandrogenSponsor Protocol Number56021927PCR3002Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)68.4

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

Approved Data Requests Associated with this Trial

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