Therapy Detail
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| Therapy Name | Darolutamide |
| Synonyms | |
| Therapy Description |
Nubeqa (darolutamide) is an androgen receptor antagonist that binds to and prevents nuclear translocation of the androgen receptor, thereby inhibiting expression of genes downstream of androgen receptor signaling that regulate proliferation of prostate cancer cells (PMID: 28490267). Nubeqa (darolutamide) is FDA approved for use in patients with non-metastatic castration-resistant prostate cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Darolutamide | Nubeqa | BAY1841788|ODM-201 | Hormone - Anti-androgens 38 | Nubeqa (darolutamide) is an androgen receptor antagonist that binds to and prevents nuclear translocation of the androgen receptor, thereby inhibiting expression of genes downstream of androgen receptor signaling that regulate proliferation of prostate cancer cells (PMID: 28490267). Nubeqa (darolutamide) is FDA approved for use in patients with non-metastatic castration-resistant 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 |
|---|---|---|---|---|---|---|
| NCT04736199 | Phase III | Darolutamide | Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE) | Recruiting | ESP | CAN | 14 |
| NCT03385655 | Phase II | Savolitinib Darolutamide Adavosertib | Prostate Cancer Biomarker Enrichment and Treatment Selection | Recruiting | CAN | 0 |
| NCT04025372 | Phase II | Bicalutamide Darolutamide | INTREPId (INTermediate Risk Erection PreservatIon Trial) | Recruiting | USA | 0 |
| NCT04335682 | Phase II | Darolutamide Enzalutamide | Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide | Recruiting | USA | 0 |
| NCT04136353 | Phase III | Darolutamide | Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (DASL-HiCaP) | Recruiting | USA | CAN | 4 |
| NCT05059236 | Phase II | Darolutamide | A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study. (ARASEC) | Recruiting | USA | 0 |
| NCT02799602 | Phase III | Darolutamide Darolutamide + Docetaxel | ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 16 |
| NCT04319783 | Phase II | Darolutamide | Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) | Recruiting | 1 | |
| NCT04237584 | Phase III | Darolutamide Darolutamide + Radium Ra 223 dichloride Enzalutamide Enzalutamide + Radium Ra 223 dichloride | A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients (ESCALATE) | Terminated | USA | 0 |
| NCT05346848 | Phase II | Darolutamide | A Randomized Phase II Trial on Short Term Darolutamide Concomitant to Radiation Therapy for Patients With Intermediate Unfavorable Risk Prostate Cancer (DARIUS) | Not yet recruiting | FRA | 0 |
| NCT04641078 | Phase II | Darolutamide | Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer (DART) | Recruiting | BEL | 0 |
| NCT04464226 | Phase III | Darolutamide | Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 31 |
| NCT04916613 | Phase III | Darolutamide | ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Unfit) | Recruiting | FRA | 0 |
| NCT03004534 | Phase 0 | Darolutamide | A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of ODM-201 | Completed | USA | DEU | CAN | 0 |
| NCT03383679 | Phase II | Darolutamide Capecitabine | Study on Androgen Receptor and Triple Negative Breast Cancer (START) | Active, not recruiting | FRA | 0 |
| NCT02200614 | Phase III | Darolutamide | Efficacy and Safety Study of ODM-201 in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 28 |
| NCT04157088 | Phase II | Enzalutamide Darolutamide | Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC) (DaroAcT) | Active, not recruiting | USA | 0 |
| NCT02972060 | Phase II | Triptorelin Leuprolide Degarelix Goserelin Darolutamide | ODM-201 vs Androgen Deprivation Therapy in Hormone naive Prostate Cancer | Unknown status | ESP | BEL | 0 |
| NCT04070209 | Phase II | Darolutamide | Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) | Recruiting | CAN | 0 |
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