Study Phase 3

A Randomized, Double-blind, Comparative Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Subjects With High-Risk, Metastatic Hormone-naive Prostate Cancer (mHNPC)

Trial Information

Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsEnrollment1209% FemaleN/A% WhiteN/A
Product ClassEndocrine TherapySponsor Protocol Number212082PCR3011Data PartnerJohnson & JohnsonCondition StudiedNeoplasms, ProstaticMean/Median Age (Years)67.1

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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