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 patients, the cancer eventually progresses to become resistant to existing therapies. This warrants further treatment.
The goal of treatment with darolutamide is to delay the progression of prostate cancer to metastatic disease, increasing quality of life and life expectancy for those with advanced prostate cancer. Darolutamide was developed by Bayer HealthCare Pharmaceuticals Inc. and approved by the FDA on July 30th, 2019.
- 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
Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.
- Conditions
- Genitourinary Cancers
- Interventions
- First Posted Date
- 2024-12-09
- Last Posted Date
- 2025-05-21
- 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
- Prostate Cancer
- Interventions
- Drug: Physician choice Androgen Deprivation (Hormone) Therapy
- 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
A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer (mHSPC)Low-volume Metastasis
- Interventions
- First Posted Date
- 2024-10-28
- Last Posted Date
- 2025-05-21
- Lead Sponsor
- Bayer
- Target Recruit Count
- 100
- Registration Number
- NCT06661122
- Locations
- 🇯🇵
Many locations, Multiple Locations, Japan
PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer
- Conditions
- Prostate CancerMetastatic CancerCastrate Sensitive Prostate Cancer
- First Posted Date
- 2024-10-22
- Last Posted Date
- 2025-03-12
- Target Recruit Count
- 152
- Registration Number
- NCT06652607
- Locations
- 🇮🇹
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC ONCOLOGIA MEDICA, Roma, Lazio, Italy
Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer
- Conditions
- Prostate CAProstate Cancer (Adenocarcinoma)Prostate Cancer Surgery
- 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
COACTION Trial - COmbination Androgen bloCkade in inTermediate to hIgh-risk prOstate caNcer
- Conditions
- Prostate Cancer
- Interventions
- First Posted Date
- 2024-10-04
- Last Posted Date
- 2024-10-04
- Lead Sponsor
- Brazilian Clinical Research Institute
- Target Recruit Count
- 144
- Registration Number
- NCT06627530
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
- High Risk Prostate CarcinomaProstate Cancer
- Interventions
- Drug: ADT (Standard of Care)Radiation: Stereotactic Body RadioTherapy (SBRT)Radiation: radiotherapy
- First Posted Date
- 2024-10-03
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- UNICANCER
- Target Recruit Count
- 700
- Registration Number
- NCT06625970
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Interventions
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-04-22
- Lead Sponsor
- Canadian Cancer Trials Group
- Target Recruit Count
- 830
- Registration Number
- NCT06592924
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
Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients
- Conditions
- Prostate CancerHormone Sensitive Prostate CancerMetastatic Tumor
- Interventions
- First Posted Date
- 2024-06-25
- Last Posted Date
- 2024-06-25
- Lead Sponsor
- Santa Chiara Hospital
- Target Recruit Count
- 3000
- Registration Number
- NCT06473259
- Locations
- 🇮🇹
Azienda Ospedaliera San Luigi, Orbassano, Torino, Italy
🇮🇹Istituto Oncologico Veneto, Padova, Italy
🇮🇹Santa Chiara Hospital, Trento, Italy
Drug Development Updates
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