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Conditions: Metastatic Hormone-sensitive Prostate Cancer
Interventions: BAY1841788 / darolutamide (ODM-201), Standard ADT (androgen deprivation therapy), Docetaxel, Placebo; Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 1,306 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2016 – 2023
U.S. locations: 58
States / cities: Chandler, Arizona • Tucson, Arizona • Beverly Hills, California + 52 more

Conditions: Metastatic Castration Resistant Prostate Cancer
Interventions: Rinzimetostat, Darolutamide, Enzalutamide, Docetaxel; Drug
Lead sponsor: ORIC Pharmaceuticals; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 600 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 11
States / cities: Coral Springs, Florida • Jeffersonville, Indiana • Holland, Michigan + 8 more

Conditions: Prostate Adenocarcinoma, Prostate Cancer, Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi], Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan; Drug · Diagnostic Test
Lead sponsor: Beth Israel Deaconess Medical Center; Other
Eligibility: 40 Years and older · Male only
Enrollment: 9 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2026
U.S. locations: 1
States / cities: Boston, Massachusetts

Conditions: Prostate Cancer
Interventions: Darolutamide, Placebo oral tablet, Luteinizing Hormone-Releasing Hormone Analog, External Beam Radiotherapy; Drug · Radiation
Lead sponsor: University of Sydney; Other
Eligibility: 18 Years and older · Male only
Enrollment: 1,100 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2028
U.S. locations: 19
States / cities: Boston, Massachusetts • Brighton, Massachusetts • Burlington, Massachusetts + 15 more

Conditions: Prostate Cancer (Adenocarcinoma)
Interventions: Abiraterone, Enzalutamide, Apalutamide, Darolutamide (BAY 1841788), Docetaxel, ADT; Drug
Lead sponsor: Canadian Cancer Trials Group; Network
Eligibility: 18 Years and older · Male only
Enrollment: 830 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2031
U.S. locations: 374
States / cities: Anchorage, Alaska • Fairbanks, Alaska • Phoenix, Arizona + 272 more

Conditions: Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
Interventions: Darolutamide, Abiraterone acetate, Enzalutamide, Apalutamide; Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 1,400 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2026
U.S. locations: 1
States / cities: Cleveland, Ohio

Conditions: Prostate Cancer
Interventions: Darolutamide, Physician choice Androgen Deprivation (Hormone) Therapy; Drug
Lead sponsor: University of Chicago; Other
Eligibility: 18 Years and older · Male only
Enrollment: 80 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2029
U.S. locations: 1
States / cities: Chicago, Illinois

Conditions: Prostate Cancer
Interventions: No intervention; Other
Lead sponsor: Bayer; Industry
Eligibility: 55 Years and older · Male only
Enrollment: 3,000 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2027
U.S. locations: 1
States / cities: Whippany, New Jersey

Conditions: Prostate Cancer Non-Metastatic, Castration-Resistant
Interventions: Darolutamide (Nubeqa, BAY1841788), Placebo; Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 1,509 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2014 – 2021
U.S. locations: 55
States / cities: Homewood, Alabama • Anchorage, Alaska • Tucson, Arizona + 48 more

Conditions: Castration-Resistant Prostatic Neoplasms
Interventions: Cetrelimab 480 mg, Apalutamide 240 mg; Drug
Lead sponsor: Janssen Research & Development, LLC; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 33 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2021
U.S. locations: 11
States / cities: San Francisco, California • Shreveport, Louisiana • Ann Arbor, Michigan + 7 more

Conditions: Cancer
Interventions: Darolutamide (Nubeqa, BAY1841788); Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 402 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2028
U.S. locations: 36
States / cities: Homewood, Alabama • Chandler, Arizona • Los Angeles, California + 31 more

Conditions: Metastatic Castration-resistant Prostate Neoplasms, Metastatic Hormone-sensitive Prostate Cancer
Interventions: Pasritamig, Cetrelimab, Cabazitaxel, Docetaxel, Apalutamide, Enzalutamide, Darolutamide, Abiraterone acetate plus prednisone (AAP), Lutetium Lu-177 vipivotide tetraxetan, JNJ-101556143; Drug
Lead sponsor: Janssen Research & Development, LLC; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 300 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2028
U.S. locations: 7
States / cities: Sarasota, Florida • Grand Rapids, Michigan • St Louis, Missouri + 4 more

Conditions: Prostate Cancer (Adenocarcinoma), mCRPC (Metastatic Castration-resistant Prostate Cancer)
Interventions: Talazoparib with enzalutamide, Talazoparib; Drug
Lead sponsor: Prostate Cancer Clinical Trials Consortium; Other
Eligibility: 18 Years and older · Male only
Enrollment: 126 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 8
States / cities: Duarte, California • La Jolla, California • Boston, Massachusetts + 5 more

Conditions: Metastatic Prostate Cancer, Non-metastatic Prostate Cancer, Prostate Cancer
Interventions: Darolutamide, Abemaciclib, GNRH-A Leuprolide Acetate, GNRH-A Goserelin, Degarelix; Drug
Lead sponsor: Praful Ravi, MB BCHir, MRCP; Other
Eligibility: 18 Years and older · Male only
Enrollment: 9 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2026
U.S. locations: 1
States / cities: Boston, Massachusetts

Conditions: Metastatic Castration Resistant Prostate Cancer (mCRPC)
Interventions: AAA617, ARPI: Abiraterone, ARPI: Enzalutamide; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years to 100 Years · Male only
Enrollment: 7 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2026
U.S. locations: 5
States / cities: Casa Grande, Arizona • Gilbert, Arizona • Newport Beach, California + 2 more

Conditions: Prostate Carcinoma
Interventions: Darolutamide, Goserelin Acetate, Leuprolide Acetate, Placebo Administration, Quality-of-Life Assessment, Triptorelin; Drug · Other
Lead sponsor: ECOG-ACRIN Cancer Research Group; Network
Eligibility: 18 Years and older · Male only
Enrollment: 27 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2028
U.S. locations: 115
States / cities: Duarte, California • Los Angeles, California • Palo Alto, California + 88 more

Conditions: Castrate Resistant Prostate Cancer
Interventions: Ipatasertib, Darolutamide, Androgen Deprivation Therapy; Drug
Lead sponsor: David VanderWeele; Other
Eligibility: 18 Years and older · Male only
Enrollment: 6 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2022
U.S. locations: 3
States / cities: Chicago, Illinois • Indianapolis, Indiana • Hershey, Pennsylvania

Conditions: Metastatic Hormone-sensitive Prostate Cancer
Interventions: Darolutamide (BAY1841788, Nubeqa), ADT; Drug · Other
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 223 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2026
U.S. locations: 31
States / cities: Homewood, Alabama • Tucson, Arizona • Los Angeles, California + 24 more

Conditions: Biochemically Recurrent Prostate Cancer
Interventions: Darolutamide (BAY1841788, Nubeqa), Placebo matching darolutamide, ADT; Drug · Other
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 985 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2030
U.S. locations: 25
States / cities: Phoenix, Arizona • Duarte, California • Los Angeles, California + 18 more

Conditions: Metastatic Castration Resistant Prostate Cancer
Interventions: Pembrolizumab; Drug
Lead sponsor: VA Office of Research and Development; Federal
Eligibility: 18 Years and older · Male only
Enrollment: 40 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2026
U.S. locations: 13
States / cities: San Francisco, California • West Los Angeles, California • Washington D.C., District of Columbia + 10 more

Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: Enzalutamide during Lead-in Period, Lead-in Enzalutamide followed by Radium-223/Enzalutamide, Lead-in Enzalutamide followed by Placebo/Enzalutamide, Darolutamide during Lead-in Period, Lead-in Darolutamide followed by Radium-223/Darolutamide, Lead-in Darolutamide followed by Placebo/Darolutamide; Drug
Lead sponsor: MANA RBM; Other
Eligibility: 18 Years and older · Male only
Enrollment: 23 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2022
U.S. locations: 1
States / cities: Myrtle Beach, South Carolina

Conditions: Advanced Solid Tumor
Interventions: SNV1521, DB-1310, Abiraterone, Darolutamide; Drug
Lead sponsor: ParVation Therapeutics, Inc.; Industry
Eligibility: 18 Years and older
Enrollment: 400 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2027
U.S. locations: 5
States / cities: New Haven, Connecticut • Philadelphia, Pennsylvania • Nashville, Tennessee + 2 more

Conditions: Prostate Cancer
Interventions: Saruparib (AZD5305), Darolutamide, No Treatment; Drug · Other
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 113 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2026
U.S. locations: 2
States / cities: Detroit, Michigan • Providence, Rhode Island

Conditions: Metastatic Prostate Cancer, Prostate Cancer Metastatic, Prostate Cancer, Castrate Resistant Prostate Cancer, Hormone Sensitive Prostate Cancer, Non-metastatic Prostate Cancer
Interventions: Darolutamide, Enzalutamide; Drug
Lead sponsor: Alliance Foundation Trials, LLC.; Other
Eligibility: 18 Years and older · Male only
Enrollment: 111 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2026
U.S. locations: 8
States / cities: San Francisco, California • Chicago, Illinois • Fairway, Kansas + 4 more

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Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)

Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

A 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 Clinics

Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

A Study to Learn About Heart-Related Risks in Elderly Men With Advanced Prostate Cancer Treated With Enzalutamide or Darolutamide

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

A Study of Cetrelimab (JNJ-63723283), a Programmed Cell Death Receptor-1 (PD-1) Inhibitor, Administered in Combination With Apalutamide in Participants With Metastatic Castration-Resistant Prostate Cancer

Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate Cancer

A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

A Study to Learn How Well Darolutamide Administered Together With Androgen Deprivation Therapy (ADT) Works in Men With Metastatic Hormone-sensitive Prostate Cancer. Results Will be Compared With ADT Alone From a Previously Conducted Study.

A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients

SNV1521 in Participants With Advanced Solid Tumors

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

Androgen Receptor Directed Therapy on Cognitive Function in Patients Treated With Darolutamide or Enzalutamide