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, 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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  • Use quotes to match a longer phrase which contains spaces "mtor c1483f"

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT04025372 Phase II Bicalutamide Darolutamide INTREPId (INTermediate Risk Erection PreservatIon Trial) Recruiting USA 0
NCT04916613 Phase III Darolutamide ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Unfit) Recruiting FRA 0
NCT03383679 Phase II Darolutamide Capecitabine Study on Androgen Receptor and Triple Negative Breast Cancer (START) Completed FRA 0
NCT04335682 Phase II Darolutamide Enzalutamide Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide Recruiting USA 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) Recruiting USA | CAN 4
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
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
NCT04319783 Phase II Darolutamide Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA (DECREASE) Recruiting 1
NCT04641078 Phase II Darolutamide Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer (DART) Recruiting BEL 0
NCT04736199 Phase III Darolutamide Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer (ARANOTE) Recruiting ESP | CAN 14
NCT04070209 Phase II Darolutamide Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X) Recruiting CAN 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) Recruiting USA 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
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
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) Completed USA 0
NCT03385655 Phase II Savolitinib Darolutamide Adavosertib Prostate Cancer Biomarker Enrichment and Treatment Selection Recruiting CAN 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
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


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