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Compound · clinical trials

Apalutamide

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 15 trials in our USA, UK, China and India registers that name Apalutamide as an intervention. Synced 24 Sep 2026
15Trials tracked
6Recruiting now
9Lead sponsors
4Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 โ€” Top 14 finalist
Compiled from ClinicalTrials.gov registry records ยท Last verified ยท Editorial standards

Apalutamide is named as a drug or biological intervention in 15 clinical trials in our USA, UK, China and India trial registers, 6 of which are recruiting. Lead sponsors include Aragon Pharmaceuticals, Inc. (4), Janssen Research & Development, LLC (3) and AstraZeneca (2). Registered phases: Phase 3, Phase 2, Phase 1, Phase 1/2 and Observational. Conditions studied include Prostatic Neoplasms; Metastatic Prostate Cancer; Prostate Cancer.

01

Clinical trials of Apalutamide

15 trials
NCT IDStudyPhaseStatusLead sponsorRegister
NCT07611110 AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01) (ClinicalTrials.gov ↗)
Metastatic Castration-resistant Prostate Cancer
Phase 3 Recruiting AstraZeneca UK, USA, India, China
NCT05406999 Neoadjuvant Intense Endocrine Therapy for High Risk and Locally Advanced Prostate Cancer (ClinicalTrials.gov ↗)
Neoadjuvant Therapy, High Risk Prostate Cancer, Locally Advanced Prostate Cancer
Phase 2 Recruiting The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School China
NCT05422911 Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
Metastatic Cancer, Neoplasm, Prostate, Castrate-sensitive
Phase 2 Recruiting Sun Pharmaceutical Industries Limited USA
NCT07745361 Study of Oral MRT-2359 With Apalutamide in Prostate Cancer (ClinicalTrials.gov ↗)
Castration-Resistant Prostate Cancer (CRPC), Castration-Resistant Prostate Cancer, Prostate Cancer
Phase 2 Recruiting Monte Rosa Therapeutics, Inc USA
NCT06095089 A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 1 Recruiting Janssen Research & Development, LLC USA, China
NCT07406282 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 (ClinicalTrials.gov ↗)
Prostatic Neoplasms, Metastatic Hormone-Sensitive Prostate Cancer
Observational Recruiting Bayer USA
NCT05717582 Maximal Cytoreductive Therapies on Post-treatment Metastases in Pts With mHSPC During Apalutamide Plus ADT Treatment (ClinicalTrials.gov ↗)
Metastatic Prostate Cancer, Castration-Sensitive Prostate Cancer
Phase 2 Not yet open Fudan University China
NCT01946204 A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 3 Active, closed Aragon Pharmaceuticals, Inc. UK, USA
NCT02257736 An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC) (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 3 Active, closed Aragon Pharmaceuticals, Inc. UK, USA
NCT02489318 A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC (ClinicalTrials.gov ↗)
Prostate Cancer
Phase 3 Active, closed Aragon Pharmaceuticals, Inc. UK, USA, China
NCT02531516 An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 3 Active, closed Aragon Pharmaceuticals, Inc. UK, USA, China
NCT03767244 A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
Prostatic Neoplasms
Phase 3 Active, closed Janssen Research & Development, LLC UK, USA, China
NCT04557059 A Study of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer (ClinicalTrials.gov ↗)
Prostatic Neoplasms
Phase 3 Active, closed Janssen Pharmaceutica N.V., Belgium USA
NCT05367440 Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (ClinicalTrials.gov ↗)
Metastatic Prostate Cancer
Phase 1/2 Active, closed AstraZeneca UK, USA
NCT04662580 ARX517/JNJ-95298177 as Monotherapy or Combination Therapy in Subjects With Metastatic Prostate Cancer (ClinicalTrials.gov ↗)
Metastatic Prostate Cancer
Phase 1 Active, closed Janssen Research & Development, LLC USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Conditions studied

17 conditions
Condition (as registered)Trials
Prostatic Neoplasms7
Metastatic Prostate Cancer3
Prostate Cancer2
Metastatic Castration-resistant Prostate Cancer1
Metastatic Cancer1
Neoplasm, Prostate1
Castrate-sensitive1
Castrate-sensitive Prostate Cancer1
Castration-Resistant Prostate Cancer (CRPC)1
Castration-Resistant Prostate Cancer1
Prostate Cancer (Adenocarcinoma)1
Metastatic Hormone-Sensitive Prostate Cancer1
Castration-Sensitive Prostate Cancer1
Neoadjuvant Therapy1
High Risk Prostate Cancer1
Locally Advanced Prostate Cancer1
Intense Endocrine Therapy1
03

Sponsors

lead sponsor per trial
Lead sponsorTrials
Aragon Pharmaceuticals, Inc.4
Janssen Research & Development, LLC3
AstraZeneca2
Sun Pharmaceutical Industries Limited1
Monte Rosa Therapeutics, Inc1
Bayer1
Janssen Pharmaceutica N.V., Belgium1
Fudan University1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1
04

Trials by country register

A trial with sites in more than one country appears in each of those registers.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records โ€” it is not written from memory, and nothing here describes how Apalutamide works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Apalutamide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 24 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician โ€” our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us โ€” we correct promptly and log it.