Therapy Detail

Contact

Missing content? – Request curation!

Request curation for specific Genes, Variants, or PubMed publications.

Have questions, comments, or suggestions? - Let us know!

Email us at : ckbsupport@jax.org

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).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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).

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References

Filtering

  • Case insensitive filtering will display rows if any text in any cell matches the filter term
  • Use simple literal full or partial string matches
  • Separate multiple filter terms with a space. Any order may be used (i. e. a b c and c b a are equivalent )
  • Filtering will only apply to rows that are already loaded on the page. Filtering has no impact on query parameters.
  • Use quotes to match on a longer phrase with spaces (i.e. "mtor c1483f")

Sorting

  • Generally, the default sort order for tables is set to be first column ascending; however, specific tables may set a different default sort order.
  • Click on any column header arrows to sort by that column
  • Hold down the Shift key and click multiple columns to sort by more than one column. Be sure to set ascending or descending order for a given column before moving on to the next column.

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


Additional content available in CKB BOOST