A Study of Apalutamide in Participants 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
Sponsor: Janssen Research & Development, LLC
Open for Predictions · 3 endpoints
Key Facts
Primary Endpoints (CT.gov)
Percentage of Participants with Pathologic complete response (pCR)
Time frame: Approximately 4 years
Metastasis-Free Survival (MFS)
Time frame: Up to 7 years and 5 months
Secondary Endpoints
Prostate Specific Antigen (PSA)-Free Survival
Event Free Survival (EFS)
Time to Subsequent First Treatments (TTST-1)
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * High-risk disease defined by a total Gleason Sum Score greater than equal to (\>=) 4+3 (=Grade Groups \[GG\] 3-5) and \>=1 of the following 4 criteria: a) Any combination of Gleason Score 4+3 (= 3) and Gleason Score 8 (4+4 or 5+3) in \>= 6 systematic cores (with \>=1 core Gleason Score 8 \[4+4 or 5+3\] included); b) Any combination of Gleason Score 4+3 (=GG 3) and Gleason Score 8 (4+4 or 5+3) in \>=3 systematic cores and Prostate-specific antigen (PSA) \>=20 ng/mL (with \>= 1 core Gleason Score 8 \[4+4 or 5+3\] included); c) Gleason Score \>=9 (=GG 5) in at least 1 systematic or targeted core; d) At least 2 systematic or targeted cores with continuous Gleason Score \>=8 (=GG 4), each with \> 80 percent (%) involvement * Candidate for radical prostatectomy with pelvic lymph node dissection as per the investigator * Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1 * Contraceptive …
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