Numerous clinical trials evaluate the therapeutic utility of bicalutamide, administered alone or combined with targeted agents, across various stages of prostate cancer, advanced or metastatic breast cancer, and renal cell carcinoma. Spanning early phase 1 through phase 4, these studies are sponsored by academic and medical institutions. The overall research landscape reflects diverse recruitment statuses, including completed, currently recruiting, terminated, and not yet recruiting studies.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT04513717 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8 |
NRG Oncology |
2021-01-21 | PHASE3 |
| NCT07455903 | RECRUITING | Prostate Cancer; Localized Prostate Carcinoma |
Baptist Health South Florida |
2026-07-29 | PHASE2 |
| NCT06650579 | RECRUITING | Recurrent Prostate Carcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8 |
Emory University |
2025-01-31 | PHASE3 |
| NCT05979389 | RECRUITING | NAFLD; PCOS |
University of California, San Francisco |
2024-02-14 | PHASE1 |
| NCT06145308 | RECRUITING | Salivary Gland Carcinoma; Precision Therapy |
Peking Union Medical College |
2023-08-15 | PHASE2 |
| NCT05521698 | RECRUITING | Non-Muscle Invasive Bladder Urothelial Carcinoma; Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma |
University of Wisconsin, Madison |
2026-06-25 | PHASE1 |
| NCT03678025 | RECRUITING | Castration Levels of Testosterone; Metastatic Prostatic Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
SWOG Cancer Research Network |
2018-09-24 | PHASE3 |
| NCT07117851 | RECRUITING | Extramammary Paget Disease; Scrotum Disease |
Fudan University |
2025-08-01 | PHASE2 |
| NCT06365788 | RECRUITING | Triple Negative Breast Neoplasms |
Universitaire Ziekenhuizen KU Leuven |
2024-04-08 | PHASE2 |
| NCT04025372 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
Brigham and Women's Hospital |
2020-06-01 | PHASE2 |
| NCT04734730 | RECRUITING | Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8 |
City of Hope Medical Center |
2021-05-04 | PHASE2 |
| NCT07593079 | NOT_YET_RECRUITING | Prostate Cancer; Recurrent Prostate Cancer; Metastatic Prostate Cancer; Prostate Cancer Recurrent; Prostate Cancer Metastatic |
Washington University School of Medicine |
2026-07-31 | PHASE2 |
| NCT05095207 | RECRUITING | Breast Cancer; Metastasis |
Icahn School of Medicine at Mount Sinai |
2021-09-20 | PHASE1; PHASE2 |
| NCT07783282 | NOT_YET_RECRUITING | Prostate Cancer |
Astellas Pharma Global Development, Inc. |
2026-08-31 | PHASE1 |
| NCT04943536 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma |
Alessa Therapeutics Inc. |
2021-12-07 | PHASE1 |
| NCT02531516 | ACTIVE_NOT_RECRUITING | Prostatic Neoplasms |
Aragon Pharmaceuticals, Inc. |
2015-11-19 | PHASE3 |
| NCT01786265 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma; Recurrent Prostate Carcinoma |
M.D. Anderson Cancer Center |
2013-02-05 | PHASE2 |
| NCT07393867 | RECRUITING | Intermediate Risk Prostate Cancer; High Risk Prostate Cancer; Prostate Cancer |
Martin T. King, MD, PhD |
2026-04-29 | PHASE2 |
| NCT05050084 | ACTIVE_NOT_RECRUITING | Prostate Adenocarcinoma |
NRG Oncology |
2021-12-06 | PHASE3 |
| NCT02605486 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer (MBC) |
Memorial Sloan Kettering Cancer Center |
2015-11-11 | PHASE1; PHASE2 |
| NCT03458221 | RECRUITING | Recurrent Ovarian Cancer; Signal Transduction Pathway Deregulation; Therapy-Associated Cancer |
Gynaecologisch Oncologisch Centrum Zuid |
2023-01-31 | PHASE2; PHASE3 |
| NCT03090165 | ACTIVE_NOT_RECRUITING | Triple Negative Breast Cancer |
Kari Wisinski |
2018-05-07 | PHASE1; PHASE2 |
| NCT04787744 | RECRUITING | Prostate Cancer; Oligometastasis; Oligorecurrence; Recurrent Prostate Cancer; Metastatic Prostate Cancer; De Novo Prostate Cancer |
VA Office of Research and Development |
2021-07-01 | PHASE2; PHASE3 |
| NCT05327647 | RECRUITING | Non-Muscle Invasive Bladder Cancer |
CHU de Quebec-Universite Laval |
2022-06-23 | PHASE2 |
| NCT06222593 | RECRUITING | Carcinoma, Renal Cell |
State University of New York at Buffalo |
2024-10-01 | PHASE1; PHASE2 |
| NCT06528210 | WITHDRAWN | High Risk Prostate Carcinoma; Localized Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8 |
OHSU Knight Cancer Institute |
2025-04-16 | PHASE2 |
| NCT05019846 | RECRUITING | Prostate Cancer |
Marco Lorenzo Bonu |
2021-09-30 | PHASE3 |
| NCT03070886 | COMPLETED | Stage I Prostate Adenocarcinoma AJCC v7; Stage II Prostate Adenocarcinoma AJCC v7; Stage III Prostate Adenocarcinoma AJCC v7 |
NRG Oncology |
2017-04-05 | PHASE2; PHASE3 |
| NCT05513365 | RECRUITING | Salivary Duct Carcinoma |
Radboud University Medical Center |
2022-09-27 | PHASE2 |
| NCT06501911 | WITHDRAWN | Recurrent Glioblastoma; Recurrent High-grade Glioma |
University of Nebraska |
2025-04-08 | PHASE1 |
| NCT03141671 | UNKNOWN | Prostate Cancer |
Dana-Farber Cancer Institute |
2017-11-24 | PHASE2 |
| NCT05647356 | UNKNOWN | Polycystic Ovary Syndrome; Androgen Excess; Metabolic Disease |
Royal College of Surgeons, Ireland |
2023-01-01 | |
| NCT06222593 | Not yet recruiting | Carcinoma Renal Cell |
State University of New York at Buffalo |
2024-06-01 | Phase 1|Phase 2 |
| NCT06018116 | WITHDRAWN | Metastatic Urothelial Carcinoma |
CHU de Quebec-Universite Laval |
2023-11-07 | PHASE2 |
| NCT01969578 | COMPLETED | Salivary Gland Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2015-09-24 | PHASE2 |
| NCT03541928 | RECRUITING | High-risk Prostate Cancer; Prostate Cancer |
The Methodist Hospital Research Institute |
2018-08-02 | PHASE2 |
| NCT04284761 | COMPLETED | Prostate Adenocarcinoma; Lower Urinary Tract Symptoms |
Alessa Therapeutics Inc. |
2020-10-11 | PHASE1 |
| NCT03520478 | UNKNOWN | Prostate Cancer; Hormone-Dependent Prostate Cancer |
Jiangsu HengRui Medicine Co., Ltd. |
2018-05-30 | PHASE3 |
| NCT03809000 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
RTOG Foundation, Inc. |
2019-04-15 | PHASE2 |
| NCT04049747 | COMPLETED | Prostate Cancer; Non-metastatic Prostate Cancer; Prostate Adenocarcinoma |
Imperial College London |
2019-12-11 | |
| NCT03650894 | ACTIVE_NOT_RECRUITING | Breast Neoplasm Female; Breast Cancer; Breast Carcinoma; Breast Tumor |
Providence Health & Services |
2019-04-03 | PHASE2 |
| NCT02299999 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
UNICANCER |
2014-04-07 | PHASE2 |
| NCT03971110 | TERMINATED | Advanced Prostate Cancer |
AstraZeneca |
2021-01-28 | PHASE4 |
| NCT03043807 | COMPLETED | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2017-02-22 | PHASE2 |
| NCT00541047 | COMPLETED | Gastrointestinal Complications; Prostate Cancer; Sexual Dysfunction; Urinary Complications |
University College, London |
2007-11 | PHASE3 |
| NCT03147196 | WITHDRAWN | Stage I Prostate Adenocarcinoma; Stage II Prostate Adenocarcinoma |
Mayo Clinic |
2017-06-27 | PHASE2 |
| NCT04248621 | UNKNOWN | Prostatic Neoplasms |
Wonju Severance Christian Hospital |
2020-01-23 | PHASE4 |
| NCT02716974 | COMPLETED | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2016-06 | PHASE2 |
| NCT00188708 | COMPLETED | Prostatic Neoplasms |
University Health Network, Toronto |
2001-04 | |
| NCT01809691 | COMPLETED | Prostate Cancer |
SWOG Cancer Research Network |
2013-03-08 | PHASE3 |
| NCT04374279 | WITHDRAWN | COVID-19; SARS-CoV 2 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2021-04 | PHASE2 |
| NCT02346253 | COMPLETED | Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer |
Stanford University |
2015-01-13 | |
| NCT04652765 | TERMINATED | Covid19; SARS-CoV Infection; Coronavirus Infection |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2021-02-03 | PHASE1 |
| NCT03358563 | COMPLETED | Prostate Cancer |
University of Wisconsin, Madison |
2018-01-17 | EARLY_PHASE1 |
| NCT03587285 | UNKNOWN | Prostatic Neoplasms |
Guangzhou University of Traditional Chinese Medicine |
2018-09-23 | PHASE1; PHASE2 |
| NCT04509999 | WITHDRAWN | COVID-19 |
University of Florida |
2020-10-26 | PHASE3 |
| NCT00468715 | COMPLETED | Breast Cancer |
Memorial Sloan Kettering Cancer Center |
2007-03-23 | PHASE2 |
| NCT04573231 | Recruiting | Breast Cancer|HER2-negative Breast Cancer|Metastatic Breast Cancer |
University of Wisconsin Madison |
2021-05-24 | Phase 2 |
| NCT02058706 | COMPLETED | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer |
Barbara Ann Karmanos Cancer Institute |
2014-05 | PHASE2 |
| NCT02742675 | UNKNOWN | Prostate Cancer |
Fudan University |
2015-09 | PHASE2 |
| NCT03878524 | TERMINATED | 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 |
OHSU Knight Cancer Institute |
2020-04-01 | PHASE1 |
| NCT03055312 | TERMINATED | Metastatic Triple Negative Breast Cancer |
Sun Yat-sen University |
2016-12-20 | PHASE3 |
| NCT00936390 | COMPLETED | Prostate Cancer |
Radiation Therapy Oncology Group |
2009-09 | PHASE3 |
| NCT04443062 | Recruiting | Prostate Cancer |
Radboud University Medical Center|Prostaatkankerstichting|Advanced Accelerator Applications |
2020-07-20 | Phase 2 |
| NCT01342367 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
University of Chicago |
2010-12-17 | |
| NCT02918968 | COMPLETED | Prostate Cancer |
Astellas Pharma Inc |
2016-11-02 | PHASE4 |
| NCT02614859 | COMPLETED | Cancer of Prostate |
Fox Chase Cancer Center |
2015-12-01 | PHASE2 |
| NCT02458716 | COMPLETED | Metastatic Prostate Carcinoma; Metastatic Prostatic Adenocarcinoma; Prostate Carcinoma Metastatic to the Bone |
Rutgers, The State University of New Jersey |
2015-03-06 | PHASE1 |
| NCT02697032 | COMPLETED | Breast Cancer |
University Medical Center Groningen |
2016-02 | PHASE2 |
| NCT00866554 | COMPLETED | Prostate Cancer; Erectile Dysfunction; Lower Urinary Tract Symptoms |
CHU de Quebec-Universite Laval |
2009-03 | PHASE2 |
| NCT02346578 | COMPLETED | Castration-resistant Prostate Cancer |
Taro Iguchi, MD, PHD |
2014-12 | PHASE2 |
| NCT02910050 | UNKNOWN | Breast Cancer |
Xu fei |
2016-01 | PHASE2 |
| NCT01251861 | COMPLETED | Recurrent Prostate Carcinoma; Stage I Prostate Cancer AJCC v7; Stage IIA Prostate Cancer AJCC v7; Stage IIB Prostate Cancer AJCC v7; Stage III Prostate Cancer AJCC v7 |
National Cancer Institute (NCI) |
2011-03-17 | PHASE2 |
| NCT02615223 | UNKNOWN | Stage IV Prostate Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2015-11 | |
| NCT02605226 | UNKNOWN | Stage III Prostate Cancer |
Tianjin Medical University Cancer Institute and Hospital |
2015-11 | |
| NCT02487823 | TERMINATED | Non Castrate Metastatic Prostate Cancer |
Institut Paoli-Calmettes |
2014-10 | PHASE1 |
| NCT02582749 | TERMINATED | Prostate Cancer; Bone Metastases; Prostate Neoplasms |
Ajjai Alva, MD |
2016-04 | PHASE2 |
| NCT02059213 | COMPLETED | Prostate Cancer |
University of Michigan Rogel Cancer Center |
2014-06 | PHASE2 |
| NCT00004124 | COMPLETED | Prostate Cancer |
SWOG Cancer Research Network |
1999-10-15 | PHASE3 |
| NCT02353988 | UNKNOWN | Breast Neoplasms |
Jinling Hospital, China |
2015-01 | PHASE2 |
| NCT02085252 | COMPLETED | Prostate Cancer |
Takeda |
2013-06-03 | PHASE3 |
| NCT02910050 | Unknown status | Breast Cancer |
Xu fei|Sun Yat-sen University |
2016-01 | Phase 2 |
| NCT01658527 | WITHDRAWN | Prostate Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2014-01 | PHASE2 |
| NCT02348281 | TERMINATED | Breast Cancer |
Fudan University |
2015-01 | PHASE2 |
| NCT00814788 | COMPLETED | Prostate Cancer |
University of California, Davis |
2008-12 | PHASE2 |
| NCT00002874 | COMPLETED | Prostate Cancer |
Radiation Therapy Oncology Group |
1998-02 | PHASE3 |
| NCT00486642 | COMPLETED | Hormone-Resistant Prostate Cancer; Recurrent Prostate Carcinoma |
National Cancer Institute (NCI) |
2007-09 | PHASE2 |
| NCT01420250 | COMPLETED | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
2011-09-22 | PHASE1 |
| NCT01120236 | COMPLETED | Prostate Adenocarcinoma; Recurrent Prostate Carcinoma; Stage IV Prostate Cancer |
National Cancer Institute (NCI) |
2010-12 | PHASE2 |
| NCT02146937 | WITHDRAWN | Detectable Prostate Nodules |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2014-03 | PHASE2 |
| NCT00878436 | COMPLETED | Prostate Cancer; Prostatic Neoplasms |
NYU Langone Health |
2009-06 | PHASE1; PHASE2 |
| NCT01664923 | COMPLETED | Prostate Cancer |
Pfizer |
2012-08 | PHASE2 |
| NCT00776594 | COMPLETED | Prostate Cancer |
Dana-Farber Cancer Institute |
2008-10 | PHASE2 |
| NCT01288911 | COMPLETED | Prostatic Neoplasms |
Astellas Pharma Inc |
2011-03-22 | PHASE2 |
| NCT00658697 | COMPLETED | Prostate Cancer |
Dana-Farber Cancer Institute |
2008-06 | PHASE2 |
| NCT01642732 | TERMINATED | Prostate Cancer |
University of Michigan Rogel Cancer Center |
2012-10 | PHASE1 |
| NCT00528866 | COMPLETED | Prostate Cancer |
Radiation Therapy Oncology Group |
2008-04 | PHASE2 |
| NCT00924807 | TERMINATED | Prostate Cancer |
Beth Israel Medical Center |
2008-09 | PHASE1; PHASE2 |
| NCT00846976 | COMPLETED | Prostate Cancer |
AstraZeneca |
1994-12 | PHASE3 |
| NCT00002651 | COMPLETED | Prostate Cancer |
SWOG Cancer Research Network |
1995-05 | PHASE3 |
| NCT00470834 | COMPLETED | Neoplasms, Prostate |
GlaxoSmithKline |
2007-05 | PHASE4 |
| NCT00943956 | COMPLETED | Prostate Cancer |
Institut du Cancer de Montpellier - Val d'Aurelle |
2009-01 | PHASE1 |
| NCT00514917 | TERMINATED | Prostatic Neoplasms |
Sanofi |
2007-07 | PHASE3 |
| NCT01200810 | TERMINATED | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage IV Prostate Cancer |
National Cancer Institute (NCI) |
2010-08 | PHASE2 |
| NCT00630344 | COMPLETED | Prostate Cancer |
Dana-Farber Cancer Institute |
2008-02 | PHASE2 |
| NCT01050842 | COMPLETED | Prostate Cancer; Adenocarcinoma of the Prostate; Hormone-resistant Prostate Cancer; Stage IV Prostate Cancer |
Mayo Clinic |
2010-02 | EARLY_PHASE1 |
| NCT01020305 | TERMINATED | Prostate Cancer; Prostatic Neoplasms; Castrate-resistant Prostate Cancer (CRPC); Androgen-insensitive Prostate Cancer; Hormone-refractory Prostate Cancer; Metastatic Disease |
Sandy Srinivas |
2009-10 | PHASE1; PHASE2 |
| NCT00757692 | COMPLETED | Prostate Cancer |
British Columbia Cancer Agency |
2009-01 | PHASE2 |
| NCT00002633 | COMPLETED | Prostate Cancer |
NCIC Clinical Trials Group |
1995-02-08 | PHASE3 |
| NCT00833248 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-04 | PHASE3 |
| NCT00702923 | TERMINATED | Prostate Cancer |
University of Wisconsin, Madison |
2008-07 | PHASE1 |
| NCT00769795 | COMPLETED | Prostate Cancer |
University of Washington |
2008-10 | PHASE2 |
| NCT00666666 | COMPLETED | Adenocarcinoma of the Prostate; Stage IV Prostate Cancer |
National Cancer Institute (NCI) |
2009-07 | PHASE2 |
| NCT00777959 | COMPLETED | Prostate Cancer |
Merck Sharp & Dohme LLC |
2008-10 | PHASE2 |
| NCT00170157 | COMPLETED | Prostate Adenocarcinoma; Prostate Carcinoma; Recurrent Prostate Carcinoma; Stage III Prostate Cancer; Stage IV Prostate Cancer |
Mayo Clinic |
2004-06 | PHASE2 |
| NCT00388804 | TERMINATED | Prostate Cancer |
M.D. Anderson Cancer Center |
2005-02 | PHASE3 |
| NCT00544830 | ACTIVE_NOT_RECRUITING | PSA Level Greater Than Two; Stage IV Prostate Adenocarcinoma AJCC v7 |
City of Hope Medical Center |
2006-07-18 | PHASE2 |
| NCT00884273 | COMPLETED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-08 | PHASE3 |
| NCT00099086 | COMPLETED | Prostate Cancer |
Medical University of South Carolina |
2007-01-16 | PHASE1 |
| NCT00055731 | COMPLETED | Prostate Cancer |
UNICANCER |
2002-11-14 | PHASE3 |
| NCT01416870 | TERMINATED | Healthy |
AstraZeneca |
2010-07 | PHASE1 |
| NCT00659438 | COMPLETED | Prostate Cancer |
Genzyme, a Sanofi Company |
2008-02 | PHASE2 |
| NCT00003653 | COMPLETED | Prostate Cancer |
NCIC Clinical Trials Group |
1999-01-05 | PHASE3 |
| NCT00108732 | COMPLETED | Recurrent Prostate Carcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer |
National Cancer Institute (NCI) |
2006-02 | PHASE2 |
| NCT01416883 | TERMINATED | Healthy |
AstraZeneca |
2010-07 | PHASE1 |
| NCT00430235 | COMPLETED | Adenocarcinoma of the Prostate |
British Columbia Cancer Agency |
2007-03 | PHASE2 |
| NCT00298155 | COMPLETED | Cancer; Prostate Neoplasms |
University of Washington |
2006-07 | PHASE2 |
| NCT00831233 | TERMINATED | Prostate Cancer |
Ferring Pharmaceuticals |
2009-04 | PHASE3 |
| NCT00028769 | COMPLETED | Prostate Cancer |
SWOG Cancer Research Network |
2001-12 | PHASE2 |
| NCT00589472 | COMPLETED | Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer |
National Cancer Institute (NCI) |
2007-11 | PHASE2 |
| NCT00685633 | WITHDRAWN | Prostate Cancer |
Eastern Cooperative Oncology Group |
2008-12 | PHASE2 |
| NCT00651326 | TERMINATED | Prostate Cancer |
NCIC Clinical Trials Group |
2008-06-02 | PHASE3 |
| NCT00004054 | COMPLETED | Prostate Cancer |
Radiation Therapy Oncology Group |
2000-01 | PHASE3 |
| NCT00482807 | COMPLETED | Prostate Cancer |
University of Nebraska |
2004-08-31 | PHASE1 |
| NCT00554086 | COMPLETED | Prostate Cancer |
Canadian Urology Research Consortium |
2005-11 | PHASE2 |
| NCT02382094 | COMPLETED | Prostate Cancer |
Karolinska University Hospital |
2005-06 | PHASE3 |
| NCT00586898 | COMPLETED | Prostate; Cancer; Hormonal Cycling |
Memorial Sloan Kettering Cancer Center |
2001-07 | PHASE2 |
| NCT00328614 | COMPLETED | Prostate Cancer |
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University |
2003-03 | PHASE1 |
| NCT00521781 | TERMINATED | Prostatic Neoplasms |
The Methodist Hospital Research Institute |
2007-08 | PHASE2 |
| NCT00673205 | COMPLETED | Non-Metastatic Prostate Cancer |
AstraZeneca |
1995-09 | PHASE3 |
| NCT00657904 | COMPLETED | Non-metastatic Prostate Cancer |
AstraZeneca |
1995-08 | PHASE3 |
| NCT00094328 | COMPLETED | Puberty, Precocious |
AstraZeneca |
2004-11-22 | PHASE2 |
| NCT00021450 | COMPLETED | Prostate Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2001-04 | PHASE3 |
| NCT00512668 | TERMINATED | Adenocarcinoma of the Prostate; Recurrent Prostate Cancer |
National Cancer Institute (NCI) |
2007-09 | PHASE1 |
| NCT00233610 | COMPLETED | Prostate Cancer |
AstraZeneca |
2003-12 | PHASE3 |
| NCT00244920 | WITHDRAWN | Prostate Cancer |
OHSU Knight Cancer Institute |
2002-01 | PHASE2 |
| NCT00959335 | COMPLETED | Prostate Cancer; Hirsutism |
Sandoz |
2006-08 | PHASE1 |
| NCT00960310 | COMPLETED | Prostate Cancer; Hirsutism |
Sandoz |
2006-06 | PHASE1 |
| NCT00684905 | COMPLETED | Prostate Cancer |
Mayo Clinic |
2000-04 | PHASE2 |
| NCT01044706 | COMPLETED | Healthy |
Kremers Urban Development Company |
2005-05 | PHASE1 |
| NCT00002855 | COMPLETED | Prostate Cancer |
M.D. Anderson Cancer Center |
1996-08 | PHASE3 |
| NCT01039233 | COMPLETED | Bioequivalency |
Kremers Urban Development Company |
2005-05 | PHASE1 |
| NCT00030654 | COMPLETED | Prostate Cancer |
Radiation Therapy Oncology Group |
2002-10 | PHASE3 |
| NCT00067015 | COMPLETED | Prostate Cancer |
Memorial Sloan Kettering Cancer Center |
2003-05 | PHASE3 |
| NCT00023829 | COMPLETED | Prostate Cancer |
Radiation Therapy Oncology Group |
2001-08 | PHASE3 |
| NCT00012090 | COMPLETED | Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer |
Memorial Sloan Kettering Cancer Center |
2000-09 | PHASE2 |
| NCT00086736 | COMPLETED | Prostate Cancer |
University of Alabama at Birmingham |
2001-11 | PHASE2 |
| NCT00973050 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2003-09 | PHASE1 |
| NCT00972855 | COMPLETED | Healthy |
Teva Pharmaceuticals USA |
2003-09 | PHASE1 |
| NCT00014586 | TERMINATED | Prostate Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2001-01 | PHASE3 |
| NCT00031889 | COMPLETED | Prostate Cancer |
Swiss Cancer Institute |
2001-08 | PHASE2 |
| NCT00026377 | COMPLETED | Prostate Cancer |
University of Chicago |
2001-11 | PHASE1 |
| NCT00003026 | COMPLETED | Prostate Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
1997-04 | PHASE3 |
| NCT00841113 | COMPLETED | Prostate Cancer |
Speciality European Pharma Limited |
1999-01 | PHASE3 |
| NCT00421694 | COMPLETED | Prostate Cancer |
University of L'Aquila |
PHASE2; PHASE3 | |
| NCT00255268 | WITHDRAWN | Metastatic Prostate Cancer |
AstraZeneca |
2004-08 | PHASE4 |
| NCT00075192 | COMPLETED | Prostatic Neoplasms |
AstraZeneca |
2004-03 | PHASE1; PHASE2 |
| NCT00672282 | COMPLETED | Non-Metastatic Prostate Cancer |
AstraZeneca |
1995-10 | PHASE3 |
| NCT00551044 | COMPLETED | Prostatic Neoplasms |
Wirral University Teaching Hospital NHS Trust |
2003-08 | |
| NCT00348998 | UNKNOWN | Prostate Cancer |
Virginia Mason Hospital/Medical Center |
2006-04 | PHASE2 |
| NCT00536653 | COMPLETED | Osteoporosis |
Wirral University Teaching Hospital NHS Trust |
1999-10 | |
| NCT00418080 | COMPLETED | Prostate Cancer |
University of L'Aquila |
2002-04 | PHASE2 |
| NCT00349557 | COMPLETED | Prostate Cancer |
Benaroya Research Institute |
2006-04 | PHASE2 |
| NCT00319787 | COMPLETED | Locally Advanced Prostate Cancer |
AstraZeneca |
2003-12 | PHASE2 |
| NCT00771017 | WITHDRAWN | Prostate Cancer |
Eastern Cooperative Oncology Group |
2008-07 | PHASE2 |
| NCT00293696 | COMPLETED | Prostate Cancer |
Tampere University |
2004-10 | PHASE4 |
| NCT00003517 | WITHDRAWN | Adenocarcinoma of the Prostate; Stage III Prostate Cancer; Stage IV Prostate Cancer; Recurrent Prostate Cancer |
Burzynski Research Institute |
PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-08-17)
Check the
Bicalutamide
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.