An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
ATLAS: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
Sponsor: Aragon Pharmaceuticals, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Metastasis-Free Survival (MFS)
Time frame: 108 Months
Secondary Endpoints
Event-Free Survival (EFS) Based on Conventional Imaging Assessed By BICR
Time to PSA Progression
MFS Based on Conventional Imaging or Prostate-Specific Membrane Antigen (PSMA)-Positron Emission Tomography (PET) Imaging Assessed by BICR
Eligibility Criteria
Inclusion Criteria: * Age \>= 18 years * Indicated and planned to receive primary radiation therapy for prostate cancer * Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score \>=8 and \>=cT2c, 2) Gleason score 7, PSA \>=20 nanogram per milliliters (ng/mL), and \>=cT2c * Charlson index (CCI) \<=3 * An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1 * Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (\<) 1.5 milligram/deciliter (mg/dL) (\<133 micromoles/Liter \[mcmol/L\]), (3) platelets greater than or equal to (\>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin \>= 12.0 gram/deciliter (g/dL) (7.4 millimloes \[mmol\], independent of transfusion and/or growth factors within 3 months prior to randomization *…
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