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Erleada (apalutamide) is a second-generation antiandgrogen, that binds to the androgen receptor (AR) and inhibits downstream signaling, potentially resulting in decreased growth of AR-expressing tumors (PMID: 22266222, PMID: 23337756). Erleada (apalutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov).
|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Apalutamide||Erleada||ARN-509|JNJ-56021927||Hormone - Anti-androgens 27||Erleada (apalutamide) is a second-generation antiandgrogen, that binds to the androgen receptor (AR) and inhibits downstream signaling, potentially resulting in decreased growth of AR-expressing tumors (PMID: 22266222, PMID: 23337756). Erleada (apalutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer and metastatic castration-sensitive prostate cancer (FDA.gov).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|Unknown unknown||prostate cancer||not applicable||Apalutamide||FDA approved||Actionable||In a Phase III trial that supported FDA approval, treatment with Erleada (apalutamide) resulted in a median metastasis-free survival of 40.5 months in patients with non-metastatic castration-resistant prostate cancer, compared to 16.2 months with placebo (HR=0.28) (PMID: 29420164; NCT01946204).||detail... 29420164|
|Unknown unknown||prostate cancer||not applicable||Apalutamide||FDA approved||Actionable||In a Phase III trial (TITAN) that supported FDA approval, treatment with Erleada (apalutamide) plus androgen-deprivation therapy (ADT) resulted in a radiographic progression-free survival at 24 months in 68.2% (358/525) of patients with metastatic castration-sensitive prostate cancer, compared to 47.5% (250/527) in patients treated with ADT and placebo (HR=0.48, p<0.001), and improved overall survival at 24 months (82.4% vs 73.5%, HR=0.89, p=0.005) (PMID: 31150574; NCT02489318).||31150574 detail...|
|Unknown unknown||prostate cancer||not applicable||Apalutamide||Clinical Study||Actionable||In a clinical study, Erleada (apalutamide) demonstrated safety and efficacy, resulted in 12-week PSA response rate of 88% (22/25) and 22% (4/18), median time to PSA progression of 18.2 months and 3.7 months, in castration-resistant prostate cancer patients that were treatment-naive or those received prior abiraterone and prednisone (PMID: 28213364).||28213364|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT03279250||Phase II||Goserelin Triptorelin Abiraterone + Apalutamide + Prednisone Leuprolide Apalutamide||Effects of Apalutamide Plus LHRH Agonist or Apalutamide Plus Abiraterone Acetate Plus LHRH Agonist for Six Months for Prostate Cancer Patients at High Risk for Recurrence||Active, not recruiting|
|NCT01946204||Phase III||Apalutamide||A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)||Active, not recruiting|
|NCT01790126||Phase II||Apalutamide||The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer||Completed|
|NCT03371719||Phase II||Apalutamide||Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer||Active, not recruiting|
|NCT02949284||Phase II||Apalutamide Abiraterone + Apalutamide + Prednisone||Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery||Recruiting|
|NCT02489318||Phase III||Apalutamide||A Phase 3 Study of JNJ-56021927 Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With Low-Volume mHSPC||Active, not recruiting|
|NCT03767244||Phase III||Apalutamide Abiraterone + Apalutamide Prednisone||A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy||Recruiting|
|NCT02721979||Phase II||Apalutamide||ARN-509 in Treating Patients With Prostate Cancer Who Are in Active Surveillance||Active, not recruiting|
|NCT02578797||Phase I||Apalutamide||A JNJ-56021927 (ARN-509) QT/QTc Study||Active, not recruiting|
|NCT02906605||Phase II||Apalutamide Apalutamide + JNJ-64041809||A Study of the Clinical Activity and Safety of JNJ-64041809, a Live Attenuated Listeria Monocytogenes Immunotherapy, in Combination With Apalutamide Versus Apalutamide in Subjects With Metastatic Castration-resistant Prostate Cancer||Withdrawn|
|NCT03412396||Phase II||Apalutamide||Single Arm Study of 6-Months Neoadjuvant ARN-509 Prior to Radical Prostatectomy||Active, not recruiting|
|NCT03503344||Phase II||Apalutamide||Apalutamide With or Without Stereotactic Body Radiation Therapy in Treating Participants With Castration-Resistant Prostate Cancer (PILLAR)||Recruiting|