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Therapy Name Darolutamide + Docetaxel
Synonyms
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Darolutamide Nubeqa BAY1841788|ODM-201 Hormone - Anti-androgens 54 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).
Docetaxel Taxotere RP56976 Antimicrotubule Agent 14 Taxotere (docetaxel) binds to tubulin, inhibiting microtubule disassembly and preventing cell division (PMID: 32496783, PMID: 32366558).

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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
NCT05762536 Phase II Docetaxel Cabazitaxel + Darolutamide Darolutamide + Docetaxel Cabazitaxel Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC (DAROTAXEL) Recruiting NLD 0
NCT05676203 Phase III Darolutamide + Docetaxel A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients (ARASAFE) Recruiting DEU 0
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 + Niraparib and abiraterone acetate + Prednisolone Niraparib and abiraterone acetate + Prednisone 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
NCT06496581 Phase III Enzalutamide Abiraterone + Docetaxel + Prednisone Enzalutamide + lutetium Lu 177 vipivotide tetraxetan Abiraterone + Docetaxel + lutetium Lu 177 vipivotide tetraxetan + Prednisone Abiraterone + lutetium Lu 177 vipivotide tetraxetan + Prednisone Apalutamide + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel + lutetium Lu 177 vipivotide tetraxetan Darolutamide + Docetaxel Abiraterone + Prednisone Apalutamide Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders) Not yet recruiting FRA 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


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