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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 as monotherapy or 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 57 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 as monotherapy or 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
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
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
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 | TUR | SWE | SVK | ROU | POL | NLD | LVA | LTU | ITA | ISR | HUN | GBR | FRA | FIN | EST | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG 13
NCT07027124 Phase II Darolutamide + Pembrolizumab Pembrolizumab Darolutamide Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer Not yet recruiting USA 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 | IRL | GBR | CAN | AUS 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
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) Active, not recruiting USA | SWE | POL | NZL | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS 4
NCT03383679 Phase II Darolutamide Capecitabine Study on Androgen Receptor and Triple Negative Breast Cancer (START) Completed FRA 0
NCT04916613 Phase III Darolutamide ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Unfit) Recruiting SWE | SVK | ROU | NLD | ITA | IRL | FRA | ESP | DEU | CHE | BEL 0
NCT04736199 Phase III Darolutamide Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE) Active, not recruiting NZL | LVA | LTU | ESP | CAN | BRA | AUS 8
NCT07190300 Phase Ib/II Darolutamide Abiraterone + Tulmimetostat Darolutamide + Tulmimetostat TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC) (TulmiSTAR-02) Recruiting USA 1
NCT03385655 Phase II Savolitinib Darolutamide Adavosertib Prostate Cancer Biomarker Enrichment and Treatment Selection Active, not recruiting CAN 0
NCT06627530 FDA approved Leuprolide Darolutamide + Leuprolide Darolutamide COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer (COAction) Recruiting BRA 0
NCT06401980 Phase II Docetaxel Radium Ra 223 dichloride 177Lu-rhPSMA-10.1 Darolutamide Olaparib Cabazitaxel Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC) Recruiting CHE 0
NCT04070209 Phase II Darolutamide Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) Recruiting CAN 0
NCT04319783 Phase II Darolutamide Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) Active, not recruiting AUS 1
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
NCT05938270 Phase I Darolutamide Darolutamide + Saruparib Saruparib A Study to Investigate the Biological Effects of AZD5305, Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer. (ASCERTAIN) Recruiting USA | TUR | NLD | GBR | ESP | CAN | AUS 0
NCT06120491 Phase III Enzalutamide + Saruparib Abiraterone + Saruparib Darolutamide + Saruparib 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 | TUR | SWE | POL | NLD | ITA | HUN | GBR | FRA | FIN | ESP | DEU | CAN | BRA | BEL | AUT | AUS 10
NCT05683964 Phase I Apalutamide Darolutamide Enzalutamide Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression Recruiting USA 0
NCT05900973 Phase II Darolutamide A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer Unknown status BRA 0
NCT06625970 Phase III Darolutamide Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse (PEACE 7) Recruiting FRA 1
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
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 | TUR | SWE | SVK | ROU | POL | LVA | LTU | ITA | ISR | HUN | GBR | FRA | FIN | EST | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUT | AUS | ARG 11
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 + 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
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
NCT06660862 FDA approved Darolutamide Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer. Not yet recruiting USA 0
NCT04641078 Phase II Darolutamide Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer (DART) Recruiting BEL 0
NCT06592924 Phase III Enzalutamide Abiraterone Darolutamide Abiraterone + Docetaxel Apalutamide + Docetaxel Docetaxel + Enzalutamide Apalutamide Darolutamide + Docetaxel Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response (TRIPLE-SWITCH) Recruiting USA | CAN 0
NCT07142551 Phase II Testosterone cypionate Darolutamide + Relugolix Darolutamide Darolutamide + Triptorelin Darolutamide + Degarelix Darolutamide + Leuprolide Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response Not yet recruiting 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) Recruiting FRA 0
NCT06276465 Phase III Darolutamide Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging (PEACE8) Recruiting FRA 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
NCT02799602 Phase III Darolutamide Darolutamide + Docetaxel ODM-201 in Addition to Standard ADT and Docetaxel in Metastatic Castration Sensitive Prostate Cancer (ARASENS) Completed USA | SWE | POL | NLD | ITA | ISR | GBR | FRA | FIN | ESP | DEU | CZE | CAN | BRA | BGR | BEL | AUS 6
NCT05826509 Phase II Darolutamide SUrGery With or Without dARolutamide in High-risk and/or Locally Advanced Prostate Cancer (SUGAR) Recruiting FRA 0
NCT04335682 Phase II Darolutamide Enzalutamide Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide Active, not recruiting USA 0
NCT04025372 Phase II Bicalutamide Darolutamide INTREPId (INTermediate Risk Erection PreservatIon Trial) Active, not 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) Completed USA 0
NCT06173362 Phase II Darolutamide Abiraterone + Prednisone Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer Recruiting USA 0


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