- 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
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Showing 1–24
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- Conditions
- Biochemically Recurrent Prostate Cancer
- Interventions
- Darolutamide(BAY1841788, Nubeqa), Enzalutamide
- Drug
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 28 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2022 – 2024
- U.S. locations
- 5
- States / cities
- Sherman Oaks, California • Boston, Massachusetts • New York, New York + 1 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
- 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
- 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
- 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
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Anatomic Stage IV Breast Cancer AJCC v8, Anemia, Ann Arbor Stage III Hodgkin Lymphoma, Ann Arbor Stage III Non-Hodgkin Lymphoma, Ann Arbor Stage IV Hodgkin Lymphoma, Ann Arbor Stage IV Non-Hodgkin Lymphoma, Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Castration-Resistant Prostate Carcinoma, Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Hematopoietic and Lymphoid System Neoplasm, Locally Advanced Pancreatic Adenocarcinoma, Metastatic Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Metastatic Pancreatic Adenocarcinoma, Myelodysplastic/Myeloproliferative Neoplasm With Ring Sideroblasts and Thrombocytosis, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Primary Myelofibrosis, Recurrent Acute Lymphoblastic Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Chronic Lymphocytic Leukemia, Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Recurrent Hematologic Malignancy, Recurrent Hodgkin Lymphoma, Recurrent Myelodysplastic Syndrome, Recurrent Myelodysplastic/Myeloproliferative Neoplasm, Recurrent Myeloproliferative Neoplasm, Recurrent Non-Hodgkin Lymphoma, Recurrent Plasma Cell Myeloma, Recurrent Small Lymphocytic Lymphoma, Refractory Acute Lymphoblastic Leukemia, Refractory Acute Myeloid Leukemia, Refractory Chronic Lymphocytic Leukemia, Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelomonocytic Leukemia, Refractory Hematologic Malignancy, Refractory Hodgkin Lymphoma, Refractory Malignant Solid Neoplasm, Refractory Myelodysplastic Syndrome, Refractory Myelodysplastic/Myeloproliferative Neoplasm, Refractory Non-Hodgkin Lymphoma, Refractory Plasma Cell Myeloma, Refractory Primary Myelofibrosis, Refractory Small Lymphocytic Lymphoma, Stage II Pancreatic Cancer AJCC v8, Stage III Pancreatic Cancer AJCC v8, Stage IV Pancreatic Cancer AJCC v8, Stage IV Prostate Cancer AJCC v8, Unresectable Pancreatic Adenocarcinoma
- Interventions
- Abemaciclib, Abiraterone, Afatinib, Bevacizumab, Bicalutamide, Biospecimen Collection, Bortezomib, Cabazitaxel, Cabozantinib, Capecitabine, Carboplatin, Celecoxib, Cobimetinib, Copanlisib, Dabrafenib, Dacomitinib, Darolutamide, Dasatinib, Doxorubicin, Durvalumab, Enasidenib, Entrectinib, Enzalutamide, Erlotinib, Everolimus, Fluorouracil, Idelalisib, Imatinib, Ipilimumab, Lenvatinib, Leucovorin, Lorlatinib, Losartan, Nab-paclitaxel, Neratinib, Nivolumab, Olaparib, Oxaliplatin, Palbociclib, Panobinostat, Pembrolizumab, Pertuzumab, Ponatinib, Quality-of-Life Assessment, Regorafenib, Ruxolitinib, Sirolimus, Sorafenib, Sunitinib, Trametinib, Trastuzumab Emtansine, Tretinoin, Vemurafenib, Venetoclax, Vismodegib, Vorinostat
- Drug · Biological · Procedure + 1 more
- Lead sponsor
- OHSU Knight Cancer Institute
- Other
- Eligibility
- 21 Years and older
- Enrollment
- 2 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2020
- U.S. locations
- 1
- States / cities
- Portland, Oregon
- 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 Castration-resistant Prostate Cancer
- Interventions
- Apalutamide, Darolutamide (BAY 1841788), Enzalutamide
- Drug
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 1,375 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2023 – 2024
- U.S. locations
- 1
- States / cities
- Whippany, New Jersey
- 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, 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
- Locally Advanced Salivary Gland Carcinoma, Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Unresectable Salivary Gland Carcinoma
- Interventions
- Biopsy Procedure, Biospecimen Collection, Computed Tomography, Darolutamide, Leuprolide Acetate, Magnetic Resonance Imaging
- Procedure · Drug
- Lead sponsor
- National Cancer Institute (NCI)
- NIH
- Eligibility
- 18 Years and older
- Enrollment
- 21 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2023 – 2026
- U.S. locations
- 27
- States / cities
- Irvine, California • Los Angeles, California • Orange, California + 21 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
- Prostate CA, Prostate Cancer (Adenocarcinoma), Prostate Cancer Surgery
- Interventions
- Darolutamide, Relugolix, Radical Prostatectomy
- Drug · Procedure
- Lead sponsor
- AdventHealth
- Other
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 30 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2024 – 2026
- U.S. locations
- 1
- States / cities
- Orlando, Florida
- 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
- 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
- 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
- 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
- Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Triple-Negative Breast Carcinoma
- Interventions
- Biospecimen Collection, Breast Biopsy Procedure, Carboplatin, Cyclophosphamide, Darolutamide, Doxorubicin, Epirubicin, Magnetic Resonance Imaging, Paclitaxel, Pembrolizumab, Surgical Procedure, Ultrasound Imaging
- Procedure · Drug · Biological
- Lead sponsor
- Vandana Abramson
- Other
- Eligibility
- 18 Years and older
- Enrollment
- 51 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2025 – 2033
- U.S. locations
- 1
- States / cities
- Nashville, Tennessee
- 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 – 2027
- U.S. locations
- 66
- States / cities
- Los Angeles, California • Newark, Delaware • Boise, Idaho + 55 more
- Conditions
- Prostatic Cancer, Castration-Resistant
- Interventions
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide
- Drug
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 30 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2019 – 2022
- U.S. locations
- 7
- States / cities
- Portland, Maine • Voorhees Township, New Jersey • The Bronx, New York + 4 more
- Conditions
- Prostate Cancer
- Interventions
- Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
- Drug
- Lead sponsor
- Bayer
- Industry
- Eligibility
- 18 Years and older · Male only
- Enrollment
- 13,779 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2022 – 2025
- U.S. locations
- 1
- States / cities
- Whippany, New Jersey
- 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
- 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
- 870 participants
- Healthy volunteers
- Healthy volunteers not accepted
- Timeline
- 2022 – 2023
- U.S. locations
- 1
- States / cities
- Whippany, New Jersey