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Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: Testosterone cypionate, Luteinizing hormone-releasing hormone (LHRH) analogue, Darolutamide; Drug
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Other
Eligibility: 18 Years and older · Male only
Enrollment: 60 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2034
U.S. locations: 1
States / cities: Baltimore, Maryland

Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions: Androgen Deprivation Therapy (ADT), Androgen Receptor Pathway Inhibitor (ARPI), Prostate Radiation, Docetaxel; Drug · Radiation
Lead sponsor: Georgetown University; Other
Eligibility: 18 Years and older · Male only
Enrollment: 108 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2032
U.S. locations: 1
States / cities: Washington D.C., District of Columbia

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: 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: Prostate Cancer, Advanced Prostate Cancer, Hormone Sensitive Prostate Cancer
Interventions: Darolutamide, Relugolix; Drug
Lead sponsor: Atish Choudhury, MD; Other
Eligibility: 18 Years and older · Male only
Enrollment: 33 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2028
U.S. locations: 3
States / cities: Boston, Massachusetts

Conditions: Recurrent Castration-Sensitive Prostate Carcinoma, Recurrent Prostate Cancer, Castration-resistant Prostate Cancer, Biochemically Recurrent Prostate Carcinoma
Interventions: Abiraterone, Apalutamide, Biospecimen Collection, Bone Scan, Computed Tomography, Darolutamide, Degarelix, Enzalutamide, Goserelin, Histrelin, Leuprolide, Magnetic Resonance Imaging, Patient Observation, Positron Emission Tomography, Prednisone, Questionnaire Administration, Relugolix, Stereotactic Body Radiation Therapy, Triptorelin, Radiation Therapy, Image-Guided Therapy; Drug · Procedure · Other + 1 more
Lead sponsor: Mayo Clinic; Other
Eligibility: 18 Years and older · Male only
Enrollment: 532 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2031
U.S. locations: 3
States / cities: Phoenix, Arizona • Jacksonville, Florida • Rochester, Minnesota

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: 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 Adenocarcinoma
Interventions: Bicalutamide, Buserelin, Darolutamide, Degarelix, Flutamide, Goserelin, Histrelin, Leuprolide, Radiation Therapy, Relugolix, Triptorelin; Drug · Radiation
Lead sponsor: NRG Oncology; Other
Eligibility: 18 Years and older · Male only
Enrollment: 2,050 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2021 – 2031
U.S. locations: 567
States / cities: Birmingham, Alabama • Gilbert, Arizona • Peoria, Arizona + 432 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: Prostate Cancer, High-risk Prostate Cancer
Interventions: Darolutamide, Pembrolizumab, Lupron; Drug
Lead sponsor: Icahn School of Medicine at Mount Sinai; Other
Eligibility: 18 Years and older · Male only
Enrollment: 40 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2031
U.S. locations: 1
States / cities: New York, New York

Conditions: Prostatic Neoplasm
Interventions: AAA617, AAA517, Piflufolastat F 18, ARPI, ADT, Best supportive care; Drug · Other
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years to 100 Years · Male only
Enrollment: 49 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2026
U.S. locations: 10
States / cities: Denver, Colorado • Athens, Georgia • Indianapolis, Indiana + 7 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 Sensitive Prostate Cancer (mCSPC)
Interventions: darolutamide plus androgen deprivation therapy, Enzalutamide plus androgen deprivation therapy; Drug
Lead sponsor: Pfizer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 4,700 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026
U.S. locations: 1
States / cities: New York, New York

Conditions: Prostatic Neoplasms
Interventions: Abemaciclib, Darolutamide, LHRH agonist/antagonist; Drug
Lead sponsor: Eli Lilly and Company; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 10 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2026
U.S. locations: 3
States / cities: Springdale, Arkansas • Mineola, New York • New York, New York

Conditions: Advanced Prostate Carcinoma
Interventions: androgen receptor signaling inhibitors; Drug
Lead sponsor: UNC Lineberger Comprehensive Cancer Center; Other
Eligibility: 18 Years and older · Male only
Enrollment: 24 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2024
U.S. locations: 1
States / cities: Chapel Hill, North Carolina

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: 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: Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Interventions: Tulmimetostat, Darolutamide, Abiraterone, Prednisone/Prednisolone, Androgen Deprivation Therapy (ADT); Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 181 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2032
U.S. locations: 8
States / cities: Birmingham, Alabama • Iowa City, Iowa • Westwood, Kansas + 5 more

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Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

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

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

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Stereotactic 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 Trial

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

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

Two 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 Trial

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

Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate Cancer

A Phase II Study of AAA617 Alone and AAA617 in Combination With ARPI in Patients With PSMA PET Scan Positive CRPC

Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer

A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Abemaciclib Plus Darolutamide in Prostate Cancer That Has Spread After Initial Treatment

Physical Function During ARSI Treatment

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

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.

TulmiSTAR-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)