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ClinicalTrials.gov public records Last synced Nov 15, 2026, 10:05 AM EST

All trial information on this site comes from the official ClinicalTrials.gov public API (clinicaltrials.gov/api/v2), run by the U.S. National Library of Medicine. We only display that public information; we do not add opinions, endorsements, or any other intent. Always review the official ClinicalTrials.gov record for the latest information.

Showing 1–24 of 73 matching trials from the live ClinicalTrials.gov search.

Filters: Intervention: darolutamide Clear all

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 Castration Resistant Prostate Cancer (mCRPC)
Interventions: BAY2315497 Injection, Darolutamide(BAY1841788); Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 63 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2018 – 2024
U.S. locations: 3
States / cities: New Orleans, Louisiana • Omaha, Nebraska • New York, New York

Conditions: Non-metastatic Prostate Cancer, Non-metastatic Castration-resistant Prostate Cancer
Interventions: Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide; Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 1,800 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024
U.S. locations: 1
States / cities: Whippany, New Jersey

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: Progressive Metastatic Castrate-Resistant Prostate Cancer
Interventions: AZD4635, Durvalumab, Cabazitaxel; Drug
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years to 150 Years · Male only
Enrollment: 30 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2022
U.S. locations: 5
States / cities: Sacramento, California • Tampa, Florida • Atlanta, Georgia + 2 more

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 Adenocarcinoma, Stage III Prostate Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8
Interventions: Abiraterone, Biospecimen Collection, Darolutamide, Prednisone; Drug · Procedure
Lead sponsor: University of California, Davis; Other
Eligibility: 18 Years and older · Male only
Enrollment: 75 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2027
U.S. locations: 1
States / cities: Sacramento, California

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: Metastatic Castration-Sensitive Prostate Cancer
Interventions: Saruparib, Placebo, Abiraterone Acetate, Darolutamide, Enzalutamide; Drug
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years to 130 Years · Male only
Enrollment: 1,898 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2023 – 2031
U.S. locations: 71
States / cities: Chandler, Arizona • Gilbert, Arizona • Phoenix, Arizona + 63 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: 14
States / cities: Glendale, California • Coral Springs, Florida • Jeffersonville, Indiana + 11 more

Conditions: Prostate Cancer
Interventions: Darolutamide(Nubeqa, BAY1841788); Drug
Lead sponsor: Bayer; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 805 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2020 – 2026
U.S. locations: 24
States / cities: Homewood, Alabama • Tucson, Arizona • San Diego, California + 21 more

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: 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
Interventions: Not listed
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 1,247 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2025
U.S. locations: 1
States / cities: East Hanover, New Jersey

Conditions: mCRPC (Metastatic Castration-resistant Prostate Cancer), Prostate Cancer
Interventions: Pocenbrodib, Pocenbrodib and Darolutamide; Drug
Lead sponsor: Pathos AI, Inc.; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 120 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2029
U.S. locations: 19
States / cities: Fountain Valley, California • Los Alamitos, California • Aurora, Colorado + 16 more

Conditions: Prostate Cancer
Interventions: ODM-201; Drug
Lead sponsor: Orion Corporation, Orion Pharma; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 76 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2011 – 2015
U.S. locations: 4
States / cities: Wheat Ridge, Colorado • Norwich, Connecticut • Cleveland, Ohio + 1 more

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: Metastatic Castration-resistant Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer Patients, Metastatic Castration-resistant Prostate Cancer, mCRPC, mCRPC, mCRPC (Metastatic Castration-resistant Prostate Cancer)
Interventions: KTX-2001, KTX-2001 + Darolutamide (NUBEQA®); Drug
Lead sponsor: K36 Therapeutics, Inc.; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 144 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2028
U.S. locations: 13
States / cities: San Francisco, California • Miami, Florida • Port Saint Lucie, Florida + 8 more

Conditions: Adult Ovarian Granulosa Cell Tumor
Interventions: Biospecimen Collection, Chest Radiography, Computed Tomography, Darolutamide, Exemestane, Leuprolide Acetate, Magnetic Resonance Imaging, Positron Emission Tomography; Procedure · Drug
Lead sponsor: National Cancer Institute (NCI); NIH
Eligibility: 18 Years and older · Female only
Enrollment: 17 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2024 – 2026
U.S. locations: 66
States / cities: Los Angeles, California • Newark, Delaware • Boise, Idaho + 55 more

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 Cancer, Metastatic Castration-resistant Prostate Cancer, Castration Resistant Prostatic Cancer
Interventions: JANX007, Darolutamide; Biological · Drug
Lead sponsor: Janux Therapeutics; Industry
Eligibility: 18 Years to 100 Years · Male only
Enrollment: 272 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2022 – 2028
U.S. locations: 33
States / cities: Birmingham, Alabama • Phoenix, Arizona • Los Angeles, California + 26 more

Conditions: Metastatic Castration-resistant Prostate Cancer
Interventions: Actinium (225Ac) zadavotide guraxetan (AZD2265 [FPI-2265]), Cabazitaxel, Abiraterone, Enzalutamide, Apalutamide, Darolutamide, Deutenzalutamide, Radium-223; Drug
Lead sponsor: AstraZeneca; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 670 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 28
States / cities: Dothan, Alabama • Phoenix, Arizona • Duarte, California + 24 more

Conditions: Breast Cancer Female
Interventions: darolutamide; Drug
Lead sponsor: Translational Research in Oncology; Other
Eligibility: 18 Years and older · Female only
Enrollment: 36 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2017 – 2019
U.S. locations: 5
States / cities: Los Angeles, California • Redondo Beach, California • Santa Maria, California + 1 more

Conditions: Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
Interventions: Xaluritamig, Darolutamide, Abiraterone; Drug
Lead sponsor: Amgen; Industry
Eligibility: 18 Years and older · Male only
Enrollment: 60 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2025 – 2029
U.S. locations: 8
States / cities: San Francisco, California • Boston, Massachusetts • Minneapolis, Minnesota + 5 more

Search by objective public record fields.

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.

Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

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 of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

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

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

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

Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

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

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

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

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 Real-world Study of Characteristics, Treatment Patterns, and Clinical Outcomes Among Lutetium-177 Vipivotide Tetraxetan Treated Patients

A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC

Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

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

A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

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

Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide

Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer