Apalutamide
- Generic Name
- Apalutamide
- Brand Names
- Erleada
- Drug Type
- Small Molecule
- Chemical Formula
- C21H15F4N5O2S
- CAS Number
- 956104-40-8
- Unique Ingredient Identifier
- 4T36H88UA7
- Background
Apalutamide is a potent androgen receptor (AR) antagonist that selectively binds to the ligand-binding domain of AR and blocks AR nuclear translocation or binding to androgen response elements . It has been used in trials studying the treatment of Prostate Cancer, Hepatic Impairment, Prostatic Neoplasms, Castration-Resistant Prostate Cancer, and Prostatic Ne...
- Indication
Apalutamide is indicated for the treatment of patients with metastatic castration-sensitive prostate cancer and non-metastatic castration-resistant prostate cancer.
- Associated Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Metastatic Hormone-Sensitive Prostate Cancer (mHSPC), Non-Metastatic Castration-Resistant Prostate Cancer
- Associated Therapies
- Androgen Deprivation Therapy
ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2020-12-10
- Last Posted Date
- 2024-11-29
- Lead Sponsor
- Ambrx, Inc.
- Target Recruit Count
- 352
- Registration Number
- NCT04662580
- Locations
- 🇺🇸
The Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸UCSF, San Francisco, California, United States
🇺🇸Urology Cancer Center, XCancer Research Network, Omaha, Nebraska, United States
Study to Evaluate ctDNA of mCSPC Patients Receiving Apalutamide in Japan
- Conditions
- Interventions
- First Posted Date
- 2020-10-23
- Last Posted Date
- 2020-12-08
- Lead Sponsor
- Kindai University
- Target Recruit Count
- 100
- Registration Number
- NCT04601441
- Locations
- 🇯🇵
Kindai University Hospital, Ōsaka-sayama, Osaka, Japan
Androgen Deprivation Therapy and Apalutamide With or Without Radiation Therapy for the Treatment of Biochemically Recurrent Prostate Cancer, RESTART Study
- Conditions
- Interventions
- First Posted Date
- 2020-10-14
- Last Posted Date
- 2021-01-20
- Lead Sponsor
- M.D. Anderson Cancer Center
- Registration Number
- NCT04585932
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2020-09-21
- Last Posted Date
- 2024-12-06
- Lead Sponsor
- Janssen Pharmaceutica N.V., Belgium
- Target Recruit Count
- 694
- Registration Number
- NCT04557059
- Locations
- 🇺🇸
Urological Research Network, Hialeah, Florida, United States
🇺🇸First Urology, PSC, Jeffersonville, Indiana, United States
🇺🇸Michigan Institute of Urology, Troy, Michigan, United States
Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland
- Conditions
- Interventions
- First Posted Date
- 2020-08-28
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 34
- Registration Number
- NCT04530552
- Locations
- 🇺🇸
University of Arizona Cancer Center - Prevention Research Clinic, Tucson, Arizona, United States
🇺🇸USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸George Washington University Medical Center, Washington, District of Columbia, United States
A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
- First Posted Date
- 2020-08-21
- Last Posted Date
- 2024-12-09
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 108
- Registration Number
- NCT04523207
- Locations
- 🇺🇸
Urological Research Network, Hialeah, Florida, United States
🇺🇸Arkansas Urology, Little Rock, Arkansas, United States
🇺🇸MidLantic Urology, Bala-Cynwyd, Pennsylvania, United States
Two Studies for Patients With High Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a High Gene Risk Score, The PREDICT-RT Trial
- Conditions
- Interventions
- First Posted Date
- 2020-08-14
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- NRG Oncology
- Target Recruit Count
- 2478
- Registration Number
- NCT04513717
- Locations
- 🇺🇸
Arizona Center for Cancer Care - Gilbert, Gilbert, Arizona, United States
🇺🇸Arizona Center for Cancer Care - Phoenix, Phoenix, Arizona, United States
🇺🇸Arizona Center for Cancer Care - Scottsdale, Scottsdale, Arizona, United States
Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging
- Conditions
- Interventions
- Procedure: Computed TomographyRadiation: 3-Dimensional Conformal Radiation TherapyDrug: ApalutamideDrug: DegarelixRadiation: External Beam Radiation TherapyOther: Fluciclovine F18Drug: Goserelin AcetateDrug: Leuprolide AcetateProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyProcedure: Intensity-Modulated Proton TherapyOther: Quality-of-Life AssessmentRadiation: Intensity-Modulated Radiation TherapyOther: Questionnaire AdministrationDrug: RelugolixDrug: TriptorelinRadiation: Stereotactic Body Radiation TherapyRadiation: Volume Modulated Arc Therapy
- First Posted Date
- 2020-06-09
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- ECOG-ACRIN Cancer Research Group
- Target Recruit Count
- 804
- Registration Number
- NCT04423211
- Locations
- 🇺🇸
Rush University Medical Center, Chicago, Illinois, United States
🇺🇸Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Oral EPI-7386 in Patients with Castration-Resistant Prostate Cancer
- Conditions
- Interventions
- First Posted Date
- 2020-06-09
- Last Posted Date
- 2024-11-12
- Lead Sponsor
- ESSA Pharmaceuticals
- Target Recruit Count
- 99
- Registration Number
- NCT04421222
- Locations
- 🇺🇸
Hematology Oncology Associates of the Treasure Coast, Port St. Lucie, Florida, United States
🇺🇸Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
🇺🇸Massachusetts General Hospital, Boston, Massachusetts, United States
Patient Preference of Apalutamide Versus Enzalutamide in Patients With Recurrent or Metastatic Hormone-Sensitive Prostate Cancer
- First Posted Date
- 2020-06-01
- Last Posted Date
- 2024-01-05
- Lead Sponsor
- Chinese University of Hong Kong
- Target Recruit Count
- 74
- Registration Number
- NCT04409288
- Locations
- 🇭🇰
Prince of Wales Hospital, Shatin, Hong Kong
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.