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, and in combination with docetaxel in patients with metastatic hormone-sensitive 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 43 | 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, and in combination with docetaxel in patients with metastatic hormone-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 |
|---|---|---|---|---|---|---|
| NCT04335682 | Phase II | Darolutamide Enzalutamide | Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide | Recruiting | USA | 0 |
| NCT03383679 | Phase II | Darolutamide Capecitabine | Study on Androgen Receptor and Triple Negative Breast Cancer (START) | Completed | FRA | 0 |
| 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 |
| NCT05826509 | Phase II | Darolutamide | SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (SUGAR) | 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 |
| NCT02799602 | Phase III | Darolutamide Darolutamide + Docetaxel | ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS) | Completed | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS | 14 |
| NCT04736199 | Phase III | Darolutamide | Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE) | Active, not recruiting | ESP | CAN | AUS | 12 |
| NCT04136353 | Phase III | Darolutamide | Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (DASL-HiCaP) | Active, not recruiting | USA | GBR | CAN | AUS | 2 |
| NCT05526248 | Phase II | Enzalutamide Darolutamide | A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide (ARAMON) | Recruiting | USA | 0 |
| 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) | Terminated | USA | 0 |
| NCT05794906 | Phase III | Darolutamide | A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) With ADT in Men With Nonmetastatic Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies (ARASTEP) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | AUT | AUS | 9 |
| NCT02972060 | Phase II | Triptorelin Leuprolide Degarelix Goserelin Darolutamide | ODM-201 vs Androgen Deprivation Therapy in Hormone naive Prostate Cancer | Active, not recruiting | ITA | FRA | ESP | BEL | 0 |
| NCT04070209 | Phase II | Darolutamide | Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) | Recruiting | CAN | 0 |
| NCT04916613 | Phase III | Darolutamide | ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Unfit) | Recruiting | FRA | ESP | BEL | 1 |
| NCT05683964 | Phase I | Apalutamide Darolutamide Enzalutamide | Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression | Recruiting | USA | 0 |
| NCT05938270 | Phase I | Darolutamide AZD5305 + Darolutamide AZD5305 | A Study to Investigate the Biological Effects of AZD5305, Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (ASCERTAIN) | Recruiting | USA | GBR | ESP | CAN | AUS | 1 |
| NCT04025372 | Phase II | Bicalutamide Darolutamide | INTREPId (INTermediate Risk Erection PreservatIon Trial) | Recruiting | USA | 0 |
| NCT04641078 | Phase II | Darolutamide | Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer (DART) | Recruiting | BEL | 0 |
| 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) | Active, not recruiting | USA | 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 | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 26 |
| 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) | Recruiting | FRA | 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 | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 29 |
| NCT03385655 | Phase II | Savolitinib Darolutamide Adavosertib | Prostate Cancer Biomarker Enrichment and Treatment Selection | Recruiting | CAN | 0 |
| NCT04319783 | Phase II | Darolutamide | Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) | Recruiting | AUS | 0 |
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