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 48 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
NCT04916613 Phase III Darolutamide ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Unfit) Recruiting FRA | ESP | BEL 1
NCT06173362 Phase II Darolutamide Abiraterone + Prednisone Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer Recruiting USA 0
NCT05826509 Phase II Darolutamide SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (SUGAR) Recruiting FRA 0
NCT05116475 Phase III Darolutamide Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases (ALADDIN) Recruiting FRA 0
NCT04335682 Phase II Darolutamide Enzalutamide Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide Recruiting USA 0
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
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) Not yet recruiting USA 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
NCT06120491 Phase III AZD5305 + Enzalutamide Abiraterone + AZD5305 AZD5305 + Darolutamide Darolutamide Enzalutamide Abiraterone AZD5305 vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents (EvoPAR-PR01) Recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 15
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
NCT03385655 Phase II Savolitinib Darolutamide Adavosertib Prostate Cancer Biomarker Enrichment and Treatment Selection Active, not recruiting CAN 0
NCT06282588 Phase II Docetaxel Leuprolide Degarelix Goserelin Triptorelin Darolutamide Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers (THUNDER) Recruiting BEL 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
NCT04136353 Phase III Darolutamide Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (DASL-HiCaP) Active, not recruiting USA | NZL | GBR | CAN | AUS 1
NCT04025372 Phase II Bicalutamide Darolutamide INTREPId (INTermediate Risk Erection PreservatIon Trial) Recruiting USA 0
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
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 | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 28
NCT02799602 Phase III Darolutamide Darolutamide + Docetaxel ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS) Completed USA | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUS 13
NCT04641078 Phase II Darolutamide Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer (DART) Recruiting BEL 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 | NLD | GBR | ESP | CAN | AUS 0
NCT04319783 Phase II Darolutamide Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) Recruiting AUS 1
NCT03383679 Phase II Darolutamide Capecitabine Study on Androgen Receptor and Triple Negative Breast Cancer (START) Completed FRA 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) Recruiting FRA 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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 12
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
NCT05683964 Phase I Apalutamide Darolutamide Enzalutamide Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression 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
NCT04070209 Phase II Darolutamide Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) Recruiting CAN 0
NCT04736199 Phase III Darolutamide Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE) Active, not recruiting NZL | ESP | CAN | AUS 11


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