Intervention
Darolutamide
ClinicalTrials.gov intervention label
How to interpret these research links
Connected source recordsThis is the original ClinicalTrials.gov intervention label, found in 53 distinct published trials. Registry interventions may represent drugs, devices, procedures or other study activities. A matched term or study association does not establish product equivalence, efficacy or regulatory approval.
Data basis: current published ClinicalTrials.gov records and, where present, RxNorm, MONDO and FDA-label identifiers. See the evidence interpretation and counting methodology.
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Clinical trials
53 shownA Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)NCT07723248 · 2026-08-03
RECRUITINGAn 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 TreatmentNCT07538843 · 2026-07-31
RECRUITINGNeoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate CancerNCT07027124 · 2026-05-21
RECRUITINGAZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)NCT07611110 · 2026-05-04
RECRUITINGA Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.NCT07450599 · 2026-04-27
RECRUITINGSupraphysiologic Testosterone Priming Induces Darolutamide Extended ResponseNCT07142551 · 2026-03-09
RECRUITINGTulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)NCT07190300 · 2026-01-13
RECRUITINGA Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)NCT07244341 · 2025-12-03
RECRUITINGProstate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScoreNCT07617272 · 2025-11-09
RECRUITINGStudy Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate CancerNCT07140900 · 2025-10-07
RECRUITINGNeoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBCNCT07016399 · 2025-09-09
RECRUITINGA Study to Learn About Real-world Utilization and Outcomes of Darolutamide and Other Androgen Receptor Pathway Inhibitors (ARPIs) for Newly Diagnosed Metastatic Hormone-sensitive Prostate Cancer (de Novo mHSPC) in US Urology ClinicsNCT07406282 · 2025-07-22
RECRUITINGStudy Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of RelapseNCT06625970 · 2025-04-10
RECRUITINGDarolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)NCT06401980 · 2024-10-22
RECRUITINGNeoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate CancerNCT06631521 · 2024-10-22
RECRUITINGStereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE TrialNCT06378866 · 2024-06-03
RECRUITINGNeoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate CancerNCT06575257 · 2024-05-01
RECRUITINGGedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate CancerNCT06190899 · 2024-01-01
RECRUITINGTreatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular TracersNCT06282588 · 2023-12-13
RECRUITINGDocetaxel or Cabazitaxel With or Without Darolutamide in mCRPCNCT05762536 · 2023-11-29
RECRUITINGAbiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate CancerNCT06173362 · 2023-11-09
RECRUITINGA Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate CancerNCT05818683 · 2023-04-26
RECRUITINGStudy of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)NCT05519449 · 2022-09-15
RECRUITINGProBio: A Biomarker Driven Study in Patients With Metastatic Prostate CancerNCT03903835 · 2019-02-01
RECRUITINGTesting the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate CancerNCT07852195 · 2027-01-06
NOT_YET_RECRUITINGEvaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.NCT06660862 · 2026-11-01
NOT_YET_RECRUITINGSaruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)NCT07711002 · 2026-10-01
NOT_YET_RECRUITINGEfficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.NCT07730151 · 2026-08-01
NOT_YET_RECRUITINGDarolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate CancerNCT07476677 · 2026-04-01
NOT_YET_RECRUITINGComeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)NCT06463457 · 2024-12-13
ACTIVE_NOT_RECRUITINGStudy of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate CancerNCT04176081 · 2024-07-02
NOT_YET_RECRUITINGOutcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET StudyNCT06430411 · 2024-05-31
NOT_YET_RECRUITINGAbemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial TreatmentNCT05999968 · 2024-01-12
TERMINATEDSaruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal AgentsNCT06120491 · 2023-11-21
ACTIVE_NOT_RECRUITINGA Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.NCT05938270 · 2023-09-21
COMPLETEDDarolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPCNCT05771896 · 2023-09-01
WITHDRAWNNeo-DAB: Darolutamide and Abemaciclib in Prostate CancerNCT05617885 · 2023-08-09
COMPLETEDStudy of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate CancerNCT05367440 · 2022-06-02
ACTIVE_NOT_RECRUITINGTwo Studies for Patients With Unfavorable Intermediate 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 Higher Gene Risk Score, The Guidance TrialNCT05050084 · 2021-12-06
ACTIVE_NOT_RECRUITINGPsma Intensity Can be Altered by Androgen and Phospho-SrC ObstructionNCT04925648 · 2021-10-18
COMPLETEDAndrogen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or EnzalutamideNCT04335682 · 2021-08-17
COMPLETEDNeoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate CancerNCT04737109 · 2021-07-13
TERMINATEDExtreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)NCT04558866 · 2021-06-09
COMPLETEDDarolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMANCT04319783 · 2021-06-02
ACTIVE_NOT_RECRUITINGTesting the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE StudyNCT04484818 · 2021-03-01
ACTIVE_NOT_RECRUITINGStereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate CancerNCT04641078 · 2021-02-12
UNKNOWNPSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.NCT07428642 · 2020-09-01
COMPLETEDINTREPId (INTermediate Risk Erection PreservatIon Trial)NCT04025372 · 2020-06-01
ACTIVE_NOT_RECRUITINGSerial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME TrialNCT03878524 · 2020-04-01
TERMINATEDDarolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the ProstateNCT04136353 · 2020-03-31
ACTIVE_NOT_RECRUITINGProstate Cancer Biomarker Enrichment and Treatment SelectionNCT03385655 · 2018-08-01
ACTIVE_NOT_RECRUITINGStudy to Evaluate CCS1477 in Advanced TumoursNCT03568656 · 2018-07-23
COMPLETEDStudy on Androgen Receptor and Triple Negative Breast CancerNCT03383679 · 2018-03-14
COMPLETEDCommon conditions
Prostate Cancer21Metastatic Castration-Resistant Prostate Cancer7Metastatic Prostate Cancer5Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)4Castrate Resistant Prostate Cancer3Metastatic Hormone-sensitive Prostate Cancer3Prostate Cancer Metastatic3Hormone Sensitive Prostate Cancer2Non-metastatic Prostate Cancer2Oligometastasis2Prostate Cancer (Adenocarcinoma)2Prostatic Neoplasms2Stage IV Prostate Cancer AJCC v82Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive1Advanced Prostate Adenocarcinoma1Advanced Prostate Cancer1Advanced Prostate Carcinoma1Advanced Solid Tumors1Anatomic Stage II Breast Cancer AJCC v81Anatomic Stage IIIA Breast Cancer AJCC v81Anatomic Stage IV Breast Cancer AJCC v81Anemia1Ann Arbor Stage III Hodgkin Lymphoma1Ann Arbor Stage III Non-Hodgkin Lymphoma1Ann Arbor Stage IV Hodgkin Lymphoma1
Leading sponsors
AstraZeneca
5
Bayer
3
ECOG-ACRIN Cancer Research Group
2
UNICANCER
2
AdventHealth
1
Alliance Foundation Trials, LLC.
1
Amgen
1
Atish Choudhury, MD
1
Brigham and Women's Hospital
1
Canadian Cancer Trials Group
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1
Cancer Research Antwerp
1
Celcuity Inc
1
CellCentric Ltd.
1
Daiichi Sankyo
1
Trial status mix
RECRUITING24
ACTIVE_NOT_RECRUITING9
COMPLETED8
NOT_YET_RECRUITING7
TERMINATED3
UNKNOWN1
WITHDRAWN1
Phase mix
PHASE229
PHASE114
PHASE312
PHASE41
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Registry-derived research relationships: ClinicalTrials.gov. Raw condition and intervention labels remain distinct from canonical MONDO/RxNorm entities unless separately normalized.