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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). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Apalutamide | Erleada | ARN-509|JNJ-56021927 | Hormone - Anti-androgens 53 | 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 |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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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 | Completed | USA | 0 |
NCT05521698 | Phase I | Apalutamide | Effects of Apalutamide on EGFR Expression in Patients With Non-muscle Invasive Bladder Cancer | Not yet recruiting | USA | 0 |
NCT03503344 | Phase II | Apalutamide | Apalutamide With or Without Stereotactic Body Radiation Therapy in Treating Participants With Castration-Resistant Prostate Cancer (PILLAR) | Active, not recruiting | USA | 0 |
NCT06320067 | Phase III | Darolutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisolone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisolone Darolutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Docetaxel + Niraparib and abiraterone acetate + Prednisolone Niraparib and abiraterone acetate + Prednisone Docetaxel + Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Apalutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Enzalutamide Apalutamide + Docetaxel Docetaxel + Enzalutamide Apalutamide Abiraterone + Prednisone Darolutamide + Docetaxel | A Randomised Controlled Platform Trial Testing Treatments in Metastatic Hormone Sensitive Prostate Cancer (STAMPEDE2) | Recruiting | GBR | 0 |
NCT04787744 | Phase II | Goserelin Degarelix Relugolix Nilutamide Triptorelin Histrelin acetate Docetaxel + Prednisone Leuprolide Apalutamide Abiraterone + Prednisone Flutamide Abiraterone + Methylprednisolone Bicalutamide Docetaxel Enzalutamide | Veterans Affairs Seamless Phase II/III Randomized Trial of STAndard Systemic theRapy With or Without PET-directed Local Therapy for Oligometastatic pRosTate Cancer (VA STARPORT) | Recruiting | USA | 0 |
NCT05422911 | Phase II | Enzalutamide Abiraterone Apalutamide | Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer. | Not yet recruiting | USA | 0 |
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 |
NCT06496581 | Phase III | Enzalutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisone Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel Abiraterone + Prednisone Apalutamide | Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) | Not yet recruiting | FRA | 0 |
NCT03088124 | Phase II | Apalutamide | Active Surveillance With or Without Apalutamide Treatment in Low Risk Prostate Cancer (PC-ARN) | Unknown status | FRA | 0 |
NCT05159245 | Phase II | Vemurafenib Tepotinib Vismodegib Apalutamide Alectinib Regorafenib Entrectinib Pertuzumab + Trastuzumab Pemigatinib Atezolizumab Cobimetinib Dabrafenib + Trametinib Dabrafenib Trametinib Abemaciclib | The Finnish National Study to Facilitate Patient Access to Targeted Anti-cancer Drugs (FINPROVE) | Recruiting | FIN | 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 | Active, not recruiting | USA | POL | NLD | ITA | ISR | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUS | ARG | 4 |
NCT02721979 | Phase II | Apalutamide | ARN-509 in Treating Patients With Prostate Cancer Who Are in Active Surveillance | Terminated | USA | 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 |
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 |
NCT05884398 | Phase III | Apalutamide | A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC (LIBERTAS) | Recruiting | USA | POL | FRA | DEU | CAN | BRA | AUS | 2 |
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 |
NCT05683964 | Phase I | Apalutamide Darolutamide Enzalutamide | Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression | Recruiting | USA | 0 |
NCT06378866 | Phase II | Degarelix Goserelin Darolutamide Relugolix Triptorelin Enzalutamide Histrelin acetate Abiraterone + Prednisone Leuprolide Apalutamide | Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial (DIVINE) | Recruiting | USA | 0 |
NCT06067269 | Phase II | Apalutamide | Hormone Therapy (Apalutamide) and Image-guided Stereotactic Body Radiation Therapy for the Treatment of Patients With Prostate Cancer, HEATWAVE Trial (HEATWAVE) | Recruiting | USA | 0 |
NCT01946204 | Phase III | Apalutamide | A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN) | Active, not recruiting | USA | SWE | SVK | ROU | POL | NZL | NOR | NLD | ISR | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BEL | AUT | AUS | 4 |
NCT05534646 | Phase II | Apalutamide Apalutamide + Carotuximab | Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer | 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 |
NCT03412396 | Phase II | Apalutamide | Single Arm Study of 6-Months Neoadjuvant ARN-509 Prior to Radical Prostatectomy | Active, not recruiting | USA | 0 |
NCT05790213 | Phase II | Apalutamide | Focal Prostate Ablation With Androgen Deprivation and Novel Hormonal Therapy for Intermediate Risk Prostate Cancer | Suspended | 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 |
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 |
NCT04295447 | Phase II | Apalutamide | Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy (ADAM) | Active, not recruiting | DEU | AUT | 0 |
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 | Active, not 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 |
NCT02578797 | Phase I | Apalutamide | A JNJ-56021927 (ARN-509) QT/QTc Study | Completed | USA | NLD | GBR | CAN | 1 |
NCT05191680 | Phase III | Apalutamide | TherApeutics in Early ProState Cancer (TAPS02) | Recruiting | GBR | 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 | TUR | SWE | ROU | POL | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | AUS | ARG | 6 |