Clinical Trials

Numerous clinical trials evaluate apalutamide from Early Phase 1 through Phase 4, primarily focusing on non-metastatic and metastatic castration-resistant or hormone-sensitive prostate cancers, alongside bioequivalence studies in healthy participants. Sponsored by academic centers, cooperative research organizations, and pharmaceutical companies, these trials examine bioavailability, combination regimens, and targeted therapeutics. The overall trial landscape encompasses diverse recruitment statuses, ranging from actively recruiting and completed studies to those active, withdrawn, or terminated.

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
NCT04423211 RECRUITING
Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8
ECOG-ACRIN Cancer Research Group
 2020-10-08 PHASE3
NCT06931340 RECRUITING
Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8
Alliance for Clinical Trials in Oncology
 2025-12-01 PHASE3
NCT05367440 ACTIVE_NOT_RECRUITING
Metastatic Prostate Cancer
AstraZeneca
 2022-06-02 PHASE1; PHASE2
NCT06592924 RECRUITING
Prostate Cancer (Adenocarcinoma)
Canadian Cancer Trials Group
 2025-05-28 PHASE3
NCT06378866 RECRUITING
Recurrent Castration-Sensitive Prostate Carcinoma; Recurrent Prostate Cancer; Castration-resistant Prostate Cancer; Biochemically Recurrent Prostate Carcinoma
Mayo Clinic
 2024-06-03 PHASE2
NCT07333066 RECRUITING
Metastatic Hormone-sensitive Prostate Cancer
Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARD
 2026-06-05 PHASE3
NCT05191680 RECRUITING
Prostate Cancer
Cambridge University Hospitals NHS Foundation Trust
 2023-04-24 PHASE2
NCT07002320 RECRUITING
Metastatic Castrate-Resistant Prostate Cancer (mCRPC)
Institute of Cancer Research, United Kingdom
 2025-04-28 PHASE1; PHASE2
NCT04557059 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Janssen Pharmaceutica N.V., Belgium
 2020-11-12 PHASE3
NCT07751133 RECRUITING
Prostate Cancer; mHSPC; mCRPC
University College, London
 2026-08-28 PHASE3
NCT07611110 RECRUITING
Metastatic Castration-resistant Prostate Cancer
AstraZeneca
 2026-05-04 PHASE3
NCT04295447 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Universität Münster
 2020-12-10 PHASE2
NCT04181203 ACTIVE_NOT_RECRUITING
Prostate Cancer
UNICANCER
 2020-01-09 PHASE3
NCT04947254 RECRUITING
Prostate Carcinoma; Stage IIC Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2021-08-05 PHASE2
NCT07795177 NOT_YET_RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer
Anhui Medical University
 2026-10-01 PHASE2
NCT02703623 ACTIVE_NOT_RECRUITING
Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; Metastatic Prostate Carcinoma; PSA Progression; Stage IV Prostate Adenocarcinoma AJCC v7
M.D. Anderson Cancer Center
 2016-05-18 PHASE2
NCT04267887 ACTIVE_NOT_RECRUITING
Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8
OHSU Knight Cancer Institute
 2020-05-11 PHASE2
NCT05422911 RECRUITING
Metastatic Cancer; Neoplasm, Prostate; Castrate-sensitive; Castrate-sensitive Prostate Cancer
Sun Pharmaceutical Industries Limited
 2022-08-31 PHASE2
NCT06832774 RECRUITING
Prostate Cancer Metastatic Disease
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
 2025-08-01 PHASE2
NCT07745361 RECRUITING
Castration-Resistant Prostate Cancer (CRPC); Castration-Resistant Prostate Cancer; Prostate Cancer; Prostate Cancer (Adenocarcinoma)
Monte Rosa Therapeutics, Inc
 2026-08 PHASE2
NCT05818683 RECRUITING
Metastatic Castration-resistant Prostate Neoplasms; Metastatic Hormone-sensitive Prostate Cancer
Janssen Research & Development, LLC
 2023-04-26 PHASE1
NCT06274047 RECRUITING
Androgen Axis Suppression; Prostatectomy; Prostate Cancer
M.D. Anderson Cancer Center
 2024-09-10 PHASE3
NCT06095089 RECRUITING
Prostatic Neoplasms
Janssen Research & Development, LLC
 2023-11-01 PHASE1
NCT04812366 RECRUITING
Prostate Cancer
University of British Columbia
 2021-09-21 PHASE2
NCT05413421 RECRUITING
Metastatic Prostate Cancer
ORIC Pharmaceuticals
 2022-06-01 PHASE1
NCT07783282 NOT_YET_RECRUITING
Prostate Cancer
Astellas Pharma Global Development, Inc.
 2026-08-31 PHASE1
NCT02531516 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Aragon Pharmaceuticals, Inc.
 2015-11-19 PHASE3
NCT05649943 RECRUITING
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
 2023-03-01
NCT03902951 ACTIVE_NOT_RECRUITING
Metastatic Prostate Adenocarcinoma; Prostate Adenocarcinoma With Focal Neuroendocrine Differentiation; Recurrent Prostate Carcinoma; Stage IVB Prostate Cancer AJCC v8
Jonsson Comprehensive Cancer Center
 2021-03-17 PHASE2
NCT05534646 RECRUITING
Castration-resistant Prostate Cancer
Edwin Posadas, MD
 2023-12-27 PHASE2
NCT04662580 ACTIVE_NOT_RECRUITING
Metastatic Prostate Cancer
Janssen Research & Development, LLC
 2021-05-03 PHASE1
NCT05406999 RECRUITING
Neoadjuvant Therapy; High Risk Prostate Cancer; Locally Advanced Prostate Cancer; Intense Endocrine Therapy
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2020-02-01 PHASE2
NCT06067269 RECRUITING
Prostate Adenocarcinoma; Stage II Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIB Prostate Cancer AJCC v8
Jonsson Comprehensive Cancer Center
 2024-03-28 PHASE2
NCT03767244 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Janssen Research & Development, LLC
 2019-06-11 PHASE3
NCT03903835 RECRUITING
Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Karolinska Institutet
 2019-02-01 PHASE3
NCT05159245 RECRUITING
Advanced Cancer; Solid Tumor; Haematological Malignancy
Helsinki University Central Hospital
 2021-12-10 PHASE2
NCT04134260 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
NRG Oncology
 2020-04-16 PHASE3
NCT05884398 ACTIVE_NOT_RECRUITING
Metastatic Castrate-sensitive Prostate Cancer
Janssen Research & Development, LLC
 2023-08-31 PHASE3
NCT03821792 ACTIVE_NOT_RECRUITING
Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Carcinoma Metastatic in the Bone; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2019-07-22 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
NCT02949284 ACTIVE_NOT_RECRUITING
Stage II Prostate Adenocarcinoma; Stage III Prostate Adenocarcinoma
Rutgers, The State University of New Jersey
 2017-06-20 PHASE2
NCT05778097 NOT_YET_RECRUITING
Prostate Cancer; Biochemical Recurrence; High Risk
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2023-04-01 PHASE2
NCT05751941 ACTIVE_NOT_RECRUITING
Prostate Cancer; Metastatic Prostate Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2023-02-14 PHASE2
NCT03488810 WITHDRAWN
Prostate Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 2020-03-10 PHASE3
NCT03436654 ACTIVE_NOT_RECRUITING
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2018-06-21 PHASE2
NCT03360721 TERMINATED
Castration-Resistant Prostate Carcinoma; Prostate Adenocarcinoma Without Neuroendocrine Differentiation; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2018-03-06 PHASE2
NCT02772588 COMPLETED
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2016-05-12 PHASE2
NCT06758882 RECRUITING
High Risk Prostate Cancer
Marco Oderda
 2024-11-25 PHASE2
NCT05717582 NOT_YET_RECRUITING
Metastatic Prostate Cancer; Castration-Sensitive Prostate Cancer
Fudan University
 2023-05-01 PHASE2
NCT05683964 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma; Prostate Cancer; Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Beth Israel Deaconess Medical Center
 2023-01-19 EARLY_PHASE1
NCT03899077 UNKNOWN
Cancer of Prostate
Cancer Research Antwerp
 2019-04-05 PHASE2
NCT05960578 ACTIVE_NOT_RECRUITING
Metastatic Castration-Resistant Prostate Carcinoma; Prostate Adenocarcinoma; Stage IV Prostate Cancer AJCC v8
University of Washington
 2024-05-23 PHASE2
NCT03009981 COMPLETED
Prostate Cancer
Alliance Foundation Trials, LLC.
 2017-03-06 PHASE3
NCT03141671 UNKNOWN
Prostate Cancer
Dana-Farber Cancer Institute
 2017-11-24 PHASE2
NCT05740488 UNKNOWN
Prostate Cancer With ≤10 Bone Metastases
Zhujiang Hospital
 2022-01-07
NCT04601441 UNKNOWN
Metastatic Castration-sensitive Prostate Cancer
Kindai University
 2020-11-06 PHASE4
NCT03371719 ACTIVE_NOT_RECRUITING
Recurrent Prostate Carcinoma; Stage III Prostate Adenocarcinoma AJCC v7; Stage IV Prostate Adenocarcinoma AJCC v7
NRG Oncology
 2018-06-20 PHASE2
NCT06505278 UNKNOWN
Prostate Cancer
Sun Yat-sen University
 2024-08 PHASE2
NCT04154774 COMPLETED
Hepatic Impairment
Janssen Research & Development, LLC
 2019-11-07 PHASE1
NCT03503344 COMPLETED
Castration Levels of Testosterone; Castration-Resistant Prostate Carcinoma; PSA Progression; Stage IV Prostate Adenocarcinoma AJCC v7
University of California, San Francisco
 2019-12-17 PHASE2
NCT02811809 WITHDRAWN
Prostate Cancer
The University of Texas Health Science Center, Houston
 2020-12 PHASE2
NCT04530552 COMPLETED
Localized Prostate Carcinoma; Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8
National Cancer Institute (NCI)
 2021-07-23 PHASE2
NCT04421222 TERMINATED
Prostate Cancer
ESSA Pharmaceuticals
 2020-06-23 PHASE1
NCT03088124 COMPLETED
Low Risk Prostate Cancer
Institut Paoli-Calmettes
 2017-04-28 PHASE2
NCT03412396 ACTIVE_NOT_RECRUITING
Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2018-03-22 PHASE2
NCT05717660 UNKNOWN
Oligometastatic Hormone Sensitive Prostate Cancer
Azienda Ospedaliero-Universitaria Careggi
 2023-03-11 PHASE2
NCT04997252 UNKNOWN
High-Risk and Oligometastatic Prostate Cancer
Zhujiang Hospital
 2021-02-01
NCT03098836 COMPLETED
Prostate Cancer
Daniel George, MD
 2017-07-10 PHASE2
NCT04666129 COMPLETED
Metastatic Castration-Resistant Prostate Cancer; Metastatic Castration-Sensitive Prostate Cancer; Non-Metastatic Castration-Resistant Prostate Cancer
Sumitomo Pharma America, Inc.
 2021-02-18 PHASE1
NCT04926181 TERMINATED
Small Cell Neuroendocrine Carcinoma; Prostate Cancer; Small Cell Carcinoma
Rahul Aggarwal
 2022-03-16 PHASE2
NCT03298087 COMPLETED
Newly Diagnosed Oligometastatic Prostate Cancer
VA Office of Research and Development
 2018-07-01 PHASE2
NCT03777982 TERMINATED
Prostate Cancer
Dana-Farber Cancer Institute
 2020-04-20 PHASE3
NCT05212857 UNKNOWN
Prostate Cancer
Fudan University
 2022-04 PHASE2
NCT04523207 COMPLETED
Prostatic Neoplasms
Janssen Research & Development, LLC
 2020-08-19 PHASE2
NCT04409288 TERMINATED
Prostate Cancer
Chinese University of Hong Kong
 2020-07-20 PHASE3
NCT04108208 COMPLETED
Prostatic Neoplasms
Janssen Research & Development, LLC
 2019-12-17 PHASE4
NCT03569280 COMPLETED
Castration-Resistant Prostate Cancer
Kangpu Biopharmaceuticals, Ltd.
 2019-11-26 PHASE1
NCT03311555 COMPLETED
Prostate Cancer
Andrew J. Armstrong, MD
 2018-03-28 PHASE2
NCT05295927 TERMINATED
Prostatic Neoplasms
Janssen Research & Development, LLC
 2022-03-23 PHASE1
NCT02789878 COMPLETED
Prostate Cancer
Instituto do Cancer do Estado de São Paulo
 2019-01-24 PHASE2
NCT02903368 COMPLETED
Prostate Cancer
Dana-Farber Cancer Institute
 2016-10-19 PHASE2
NCT03551782 COMPLETED
Castration-Resistant Prostatic Neoplasms
Janssen Research & Development, LLC
 2018-06-28 PHASE1
NCT03080116 UNKNOWN
Prostate Cancer; Neoadjuvant Therapy; Androgen Antagonists; Prostatectomy
Universitaire Ziekenhuizen KU Leuven
 2019-03-28 PHASE2
NCT02913196 COMPLETED
Prostate Cancer Metastatic
Weill Medical College of Cornell University
 2016-12-30 PHASE1
NCT02106507 COMPLETED
Prostate Cancer
Memorial Sloan Kettering Cancer Center
 2014-04 PHASE1
NCT04325828 ACTIVE_NOT_RECRUITING
Salivary Gland Neoplasms
Janssen Pharmaceutical K.K.
 2020-04-07 PHASE2
NCT03279250 COMPLETED
Prostate Adenocarcinoma; Stage IIB Prostate Cancer AJCC v8; Stage IIC Prostate Cancer AJCC v8; Stage IIIA Prostate Cancer AJCC v8; Stage IIIC Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2017-10-13 PHASE2
NCT04585932 WITHDRAWN
Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Oligometastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
M.D. Anderson Cancer Center
 2020-11-24 PHASE2
NCT03173859 WITHDRAWN
Prostatic Neoplasms, Castration-Resistant
University of Athens
 2018-01 PHASE2
NCT02489318 ACTIVE_NOT_RECRUITING
Prostate Cancer
Aragon Pharmaceuticals, Inc.
 2015-11-27 PHASE3
NCT02770391 COMPLETED
Prostate Cancer
Case Comprehensive Cancer Center
 2016-10-17 PHASE2
NCT02721979 TERMINATED
Prostate Adenocarcinoma
University of Washington
 2017-11-02 PHASE2
NCT02867020 COMPLETED
Prostate Cancer
Latin American Cooperative Oncology Group
 2017-10-11 PHASE2
NCT03124433 COMPLETED
Cancer of the Prostate
Singapore General Hospital
 2017-06-20 PHASE2
NCT03365297 COMPLETED
Prostate Cancer
CCTU- Cancer Theme
 2018-06-05 PHASE2
NCT02924766 COMPLETED
Prostatic Neoplasms
Janssen Research & Development, LLC
 2016-10-03 PHASE1
NCT03523442 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Janssen Research & Development, LLC
 2018-08-31 PHASE1
NCT03093272 TERMINATED
Prostate Cancer
Dana-Farber Cancer Institute
 2017-06-23 PHASE2
NCT03802682 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-01-11 PHASE1
NCT01790126 COMPLETED
Prostate Cancer
Aragon Pharmaceuticals, Inc.
 2013-03-04 PHASE2
NCT02849990 COMPLETED
Stage III Prostate Adenocarcinoma AJCC v7; Stage III Prostate Cancer AJCC v7; Stage IV Prostate Adenocarcinoma AJCC v7; Stage IV Prostate Cancer AJCC v7
University of Washington
 2017-03-09 PHASE2
NCT02906605 WITHDRAWN
Prostatic Neoplasms, Castration-Resistant
Janssen Research & Development, LLC
 2016-10 PHASE2
NCT02257736 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Aragon Pharmaceuticals, Inc.
 2014-11-26 PHASE3
NCT01946204 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms
Aragon Pharmaceuticals, Inc.
 2013-10-14 PHASE3
NCT02578797 COMPLETED
Castration-Resistant Prostate Cancer
Aragon Pharmaceuticals, Inc.
 2015-12-18 PHASE1
NCT02123758 ACTIVE_NOT_RECRUITING
Prostatic Neoplasms; Metastatic Castration-Resistant Prostate Cancer
Aragon Pharmaceuticals, Inc.
 2014-07-09 PHASE1
NCT01792687 COMPLETED
Prostate Cancer
Aragon Pharmaceuticals, Inc.
 2013-02-05 PHASE1
NCT01822041 COMPLETED
Healthy
Aragon Pharmaceuticals, Inc.
 2013-03 PHASE1
NCT01171898 COMPLETED
Prostate Cancer
Aragon Pharmaceuticals, Inc.
 2010-07-26 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-17)

Check the ARN-509 (Apalutamide) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Apalutamide (ARN-509) selectively binds to the ligand-binding domain of the androgen receptor with high affinity, competitively inhibiting androgen binding and preventing nuclear translocation as well as androgen response element DNA binding. This inhibition disrupts androgen receptor-mediated transcriptional activation and downstream oncogenic signaling pathways, suppressing cellular proliferation and driving tumor regression in androgen-dependent and castration-resistant prostate cancer clinical contexts.

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>).

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Note: Technical data last updated: Sep 1, 2026.