Darolutamide
- Generic Name
- Darolutamide
- Brand Names
- Nubeqa
- Drug Type
- Small Molecule
- Chemical Formula
- C19H19ClN6O2
- CAS Number
- 1297538-32-9
- Unique Ingredient Identifier
- X05U0N2RCO
- Background
Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists. Though prior treatment for prostate cancer has been successful for these patient...
- Indication
Darolutamide is indicated for the treatment of adults with non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel.
- Associated Conditions
- Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Non-Metastatic Castration-Resistant Prostate Cancer
- Associated Therapies
- -
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
- Conditions
- Interventions
- First Posted Date
- 2024-12-09
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Spanish Oncology Genito-Urinary Group
- Target Recruit Count
- 500
- Registration Number
- NCT06724159
- Locations
- 🇪🇸
Hospital Universitario Torrecárdenas, Almería, Andalucia, Spain
🇪🇸Hospital Universitario Reina Sofía, Córdoba, Andalucia, Spain
🇪🇸Hospital Universitario Clínico San Cecilio, Granada, Andalucia, Spain
Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.
- Conditions
- Interventions
- First Posted Date
- 2024-10-28
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- University of Chicago
- Target Recruit Count
- 80
- Registration Number
- NCT06660862
- Locations
- 🇺🇸
o University of Chicago Medicine Comprehensive Cancer Center, Chicago, Illinois, United States
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2024-10-08
- Last Posted Date
- 2024-10-30
- Lead Sponsor
- AdventHealth
- Target Recruit Count
- 30
- Registration Number
- NCT06631521
- Locations
- 🇺🇸
AdventHealth Orlando, Orlando, Florida, United States
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
- Conditions
- Interventions
- First Posted Date
- 2024-10-03
- Last Posted Date
- 2024-10-03
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 700
- Registration Number
- NCT06625970
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
- First Posted Date
- 2024-08-28
- Last Posted Date
- 2024-08-28
- Lead Sponsor
- Xijing Hospital
- Target Recruit Count
- 80
- Registration Number
- NCT06575257
- Locations
- 🇨🇳
The First Affillated Hospital, the Air Force Medical University, Xi'an, Shanxi, China
Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)
- Conditions
- Interventions
- First Posted Date
- 2024-06-17
- Last Posted Date
- 2024-12-18
- Lead Sponsor
- Atish Choudhury, MD
- Target Recruit Count
- 33
- Registration Number
- NCT06463457
- Locations
- 🇺🇸
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
🇺🇸Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study
- First Posted Date
- 2024-05-28
- Last Posted Date
- 2024-05-28
- Lead Sponsor
- Medical University of Vienna
- Target Recruit Count
- 500
- Registration Number
- NCT06430411
Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
- Conditions
- Interventions
- First Posted Date
- 2024-05-07
- Last Posted Date
- 2024-10-24
- Lead Sponsor
- Swiss Group for Clinical Cancer Research
- Target Recruit Count
- 162
- Registration Number
- NCT06401980
- Locations
- 🇨🇭
Kantonsspital Baden, Baden, Switzerland
🇨🇭Istituto Oncologico della Svizzera Italiana (IOSI), Bellinzona, Switzerland
🇨🇭Inselspital, Bern, Switzerland
Stereotactic Body Radiation Therapy Plus Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy for Treatment of Metastatic, Recurrent Hormone-Sensitive Prostate Cancer, DIVINE Trial
- Conditions
- Interventions
- Drug: AbirateroneDrug: ApalutamideProcedure: Biospecimen CollectionProcedure: Bone ScanProcedure: Computed TomographyDrug: DarolutamideDrug: DegarelixDrug: EnzalutamideDrug: GoserelinDrug: HistrelinDrug: LeuprolideProcedure: Magnetic Resonance ImagingOther: Patient ObservationProcedure: Positron Emission TomographyDrug: PrednisoneOther: Questionnaire AdministrationDrug: RelugolixRadiation: Stereotactic Body Radiation TherapyDrug: Triptorelin
- First Posted Date
- 2024-04-23
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 120
- Registration Number
- NCT06378866
- Locations
- 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States
Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers
- Conditions
- Interventions
- Drug: Darolutamide matched placeboDrug: DarolutamideRadiation: RadiotherapyDrug: Zoladex 3.6Mg ImplantDrug: Zoladex LADrug: Decapeptyl sustained release 22.5 mgDrug: Decapeptyl sustained release 11.25 mgDrug: Depo-Eligard 45 mgDrug: Depo-Eligard 22.5 mgDrug: Depo-Eligard 7.5 mgDrug: Firmagon 120 MG InjectionDrug: Firmagon 80 MG InjectionDrug: Docetaxel
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2024-02-28
- Lead Sponsor
- Cancer Research Antwerp
- Target Recruit Count
- 493
- Registration Number
- NCT06282588
- Locations
- 🇧🇪
AZ Groeninge, Kortrijk, Belgium
🇧🇪GZA Sint-Augustinus, Wilrijk, Antwerp, Belgium
🇧🇪OLVZ Aalst, Aalst, Belgium
Drug Development Updates
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