Therapy Detail

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Therapy Name Apalutamide
Synonyms
Therapy Description

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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Apalutamide Erleada ARN-509|JNJ-56021927 Hormone - Anti-androgens 41 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02578797 Phase I Apalutamide A JNJ-56021927 (ARN-509) QT/QTc Study Completed USA | CAN 3
NCT04530552 Phase II Apalutamide Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland Recruiting USA 0
NCT03412396 Phase II Apalutamide Single Arm Study of 6-Months Neoadjuvant ARN-509 Prior to Radical Prostatectomy Active, not recruiting USA 0
NCT01790126 Phase II Apalutamide The Role of Highly Selective Androgen Receptor (AR) Targeted Therapy in Men With Biochemically Relapsed Hormone Sensitive Prostate Cancer Completed USA 0
NCT03088124 Phase II Apalutamide Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer (PC-ARN) Unknown status FRA 0
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 USA 0
NCT03503344 Phase II Apalutamide Apalutamide With or Without Stereotactic Body Radiation Therapy in Treating Participants With Castration-Resistant Prostate Cancer (PILLAR) Recruiting USA 0
NCT04523207 Phase II Apalutamide A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases Active, not recruiting USA 0
NCT05191680 Phase III Apalutamide TherApeutics in Early ProState Cancer (TAPS02) Recruiting 1
NCT01946204 Phase III Apalutamide A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN) Active, not recruiting USA | FRA | ESP | DEU | CAN | BEL | AUT 18
NCT02721979 Phase II Apalutamide ARN-509 in Treating Patients With Prostate Cancer Who Are in Active Surveillance Terminated USA 0
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 USA | FRA | ESP | DEU | CAN 17
NCT04295447 Phase II Apalutamide Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy (ADAM) Recruiting DEU | AUT 0
NCT05422911 Phase II Enzalutamide Abiraterone Apalutamide Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. Not yet recruiting USA 0
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 USA | ITA | FRA | ESP | DEU | CAN 12
NCT03371719 Phase II Apalutamide Radiation Therapy With or Without Apalutamide in Treating Patients With Stage III-IV Prostate Cancer Active, not recruiting USA | CAN 0
NCT05521698 Phase I Apalutamide Effects of Apalutamide on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer Not yet recruiting USA 0
NCT05534646 Phase II Apalutamide Apalutamide + Carotuximab Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer Not yet recruiting USA 0
NCT04947254 Phase II Apalutamide Abiraterone + Apalutamide + Niraparib + Prednisone Androgen Ablation Therapy With or Without Niraparib After Radiation Therapy for the Treatment of High-Risk Localized or Locally Advanced Prostate Cancer Recruiting USA 0
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 USA 0
NCT03899077 Phase II Triptorelin Goserelin Degarelix Leuprolide Apalutamide Radiotherapy Combined With a LHRH (Ant)Agonist Versus Apalutamide in Patients With Biochemical Recurrence After RP (SAVE) Recruiting BEL 0
NCT04812366 Phase II Abiraterone + Apalutamide + Prednisone Apalutamide Abiraterone + Prednisone Apalutamide + Atezolizumab Abiraterone + Docetaxel + Prednisone Abiraterone + Niraparib + Prednisone Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer (GUNS) Recruiting USA | CAN 0
NCT05790213 Phase II Apalutamide Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for Intermediate Risk Prostate Cancer Not yet recruiting USA 0
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 Completed USA 0
NCT05683964 Phase I Apalutamide Darolutamide Enzalutamide Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression Recruiting USA 0


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