A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
The purpose of this study is to determine if treatment with apalutamide plus androgen deprivation therapy (ADT) before and after radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and metastasis-free survival (MFS) as compared to placebo plus ADT.
Inclusion Criteria:
Exclusion Criteria:
Orange, California 92868, United States
Miami, Florida 33176, United States
Cheektowaga, New York 14225, United States
Charleston, West Virginia 25304, United States
Caba, 1118, Argentina
Ciudad Autonoma de, C1199ABB, Argentina
Córdoba, X5008AAC, Argentina
Goiânia, 74605-070, Brazil
São Paulo, 01246 000, Brazil
Vancouver, British Columbia V5Z 1M9, Canada
Hradec Králove, 500 05, Czechia
Braunschweig, 38126, Germany
Homburg/Saar, 66421, Germany
Weiden/Opf, 92637, Germany
Beer Yaakov, 60930, Israel
Kfar Saba, 4428164, Israel
Modena, 41100, Italy
Orbassano, 10043, Italy
Verona, 37126, Italy
Shiwa-gun, 028-3695, Japan
Bydgoszcz, 85 015, Poland
Wroclaw, 53-413, Poland
Preston, PR2 9HT, United Kingdom