Study Phase 2

A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer

Trial Information

Generic NameAbiraterone acetateProduct NameZYTIGA®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassEndocrine TherapyPharmacological SubgroupHormone Antagonists and Related AgentsChemical SubgroupOther Hormone Antagonists and Related AgentsCondition StudiedNeoplasms, Prostatic
Sponsor Protocol NumberCOU-AA-201-DFCIEnrollment58Data PartnerJohnson & Johnson% FemaleN/AMean/Median Age (Years)59% WhiteN/A

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

Disclaimer

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