Non-metastatic Castration-resistant Prostate Cancer
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CLINICAL_TRIALS research · 2026-04-20Clinical Trial Update: An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment
An observational study in China assesses the efficacy and safety of darolutamide in combination with androgen deprivation therapy for men wi…
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CLINICAL_TRIALS trial_result · 2026-04-14Clinical Trial Update: A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described
An observational study of non-metastatic castration-resistant prostate cancer patients who had already decided to be treated with darolutami…
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CLINICAL_TRIALS research · 2026-04-14Clinical Trial Update: An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea
This is an observational study in Korea assessing the safety of darolutamide in men with prostate cancer, including non-metastatic castratio…
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CLINICAL_TRIALS research · 2026-03-19Clinical Trial Update: A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) [Phase 4]
A Phase 4 clinical trial to assess safety and real-world effectiveness of adding darolutamide to standard androgen deprivation therapy in In…
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CLINICAL_TRIALS research · 2026-03-12Clinical Trial Update: PROCARE - PROstate Cancer Real World Evidence Registry
PROCARE is a prostate cancer real-world evidence registry that is currently recruiting participants, collecting data across multiple disease…
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CLINICAL_TRIALS research · 2025-12-10Clinical Trial Update: An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer
Expanded Access Protocol update for apalutamide in non-metastatic castration-resistant prostate cancer; the protocol is no longer available.
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CLINICAL_TRIALS trial_result · 2025-08-17Clinical Trial Update: Study of Relugolix in Men With Metastatic Castration-Sensitive Prostate Cancer or Non-Metastatic or Metastatic Castration-Resistant Prostate Cancer [Phase 1]
This ClinicalTrials.gov update reports the completion of a Phase 1 study evaluating relugolix in men with metastatic castration-sensitive an…
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CLINICAL_TRIALS research · 2025-06-12Clinical Trial Update: An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings
This completed observational real-world study describes and compares the use and effectiveness of darolutamide, enzalutamide, and apalutamid…
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CLINICAL_TRIALS trial_result · 2025-06-08Clinical Trial Update: Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) [Phase 1, Phase 2]
This Phase I/II trial of BN-Brachyury Vaccine, M7824, N-803, and Epacadostat in metastatic castration-resistant prostate cancer has complete…
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CLINICAL_TRIALS trial_result · 2025-03-28Clinical Trial Update: A Study of Apalutamide in Chinese Participants With Non Metastatic Castration Resistant Prostate Cancer (NM-CRPC) [Phase 4]
Phase 4 trial update for apalutamide in Chinese participants with non-metastatic castration-resistant prostate cancer; results have been pos…
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FDA approval · 2024-07-09FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) by Janssen Products, LP, prompting changes to the product labeling. The ac…
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FDA approval · 2023-12-19FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for ERLEADA (apalutamide) filed by Janssen Products, LP. The approval updates the drug's labelin…
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FDA approval · 2023-11-16FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc., updating the drug's labeling.
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FDA approval · 2023-02-17FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP. The approval expands the drug's label f…
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FDA approval · 2022-11-08FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for Erleada (apalutamide) submitted by Janssen Products, LP.
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FDA approval · 2022-08-05FDA Approved: NUBEQA — Supplemental Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved a supplemental application for NUBEQA (darolutamide) from Bayer HealthCare Pharmaceuticals Inc.
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FDA approval · 2022-04-26FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for ERLEADA (apalutamide) filed by Janssen Products, LP.
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FDA approval · 2021-07-14FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP.
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FDA approval · 2020-10-23FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
FDA approved a supplemental application for XTANDI (enzalutamide) from Astellas Pharma US to modify/expand its label for prostate cancer ind…
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FDA approval · 2020-07-10FDA Approved: ERLEADA — Supplemental Application (Janssen Products, LP)
The FDA approved a supplemental application for ERLEADA (apalutamide) submitted by Janssen Products, LP, resulting in an expanded or updated…
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FDA approval · 2019-07-30FDA Approved: NUBEQA — Original Application (Bayer HealthCare Pharmaceuticals Inc.)
The FDA approved NUBEQA (darolutamide) through an original application for the treatment of non-metastatic castration-resistant prostate can…
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CLINICAL_TRIALS trial_result · 2018-06-19Clinical Trial Update: A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer [Phase 3]
This Phase 3 clinical trial update reports results for apalutamide (ARN-509) in men with non-metastatic castration-resistant prostate cancer…
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FDA approval · 2018-02-14FDA Approved: ERLEADA — Original Application (Janssen Products, LP)
FDA approved ERLEADA (apalutamide) from Janssen Products, LP as the original NDA (NDA210951). It is approved for certain forms of prostate c…
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FDA approval · 2015-08-05FDA Approved: XTANDI — Supplemental Application (Astellas Pharma US, Inc.)
The FDA approved a supplemental application for XTANDI (enzalutamide) submitted by Astellas Pharma US, Inc. The approval expands the labelin…
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CLINICAL_TRIALS trial_result · 2012-06-01Clinical Trial Update: A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer [Phase 3]
Phase III trial of ZD4054 (Zibotentan) in non-metastatic hormone-resistant prostate cancer was terminated, with results posted in 2012.