JNJ-56021927
Sponsors
Janssen - Cilag International, Janssen Cilag International, Aragon Pharmaceuticals Inc., Universitaet Des Saarlandes, Universitaet Muenster
Conditions
Castration-Resistant Prostate CancerHealthyHepatic ImpairmentHigh risk adenocarcinoma of the prostate after radical prostatectomy
(RPE)High risk recurrent prostate cancer previously treated with radical prostatectomyHigh- or very-high riskHigh-risk biochemically-relapsed prostate adenocarcinoma following radical prostatectomy.High-risk localized or locally advanced prostate cancer
Phase 1
A Study of JNJ-56021927 (ARN-509) and Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer
Active, not recruitingNCT02123758
Start: 2014-07-09End: 2027-12-31Updated: 2026-03-13
A Safety Study of JNJ-56021927 in Participants With Metastatic Castration-Resistant Prostate Cancer
CompletedNCT02162836
Start: 2014-06-27End: 2019-05-27Updated: 2020-04-27
Study to Assess Drug-Drug Interaction Between Itraconazole or Gemfibrozil and JNJ-56021927
CompletedNCT02230033
Start: 2014-09-30End: 2014-12-31Updated: 2016-10-20
A Study to Evaluate the Pharmacokinetics of JNJ-56021927 in Participants With Mild or Moderate Hepatic Impairment Compared With Participants With Normal Hepatic Function
CompletedNCT02524717
Start: 2015-08-13End: 2017-02-09Updated: 2025-02-03
Phase 2
A feasibility trial investigating inductive Apalutamide therapy combined with radical prostatectomy in patients with locally advanced T4 high risk prostate cancer
CompletedCTIS2023-509837-37-00
Start: 2022-02-25End: 2025-09-16Target: 20Updated: 2025-05-02
A phase II, randomized, open-label study comparing salvage radiotherapy in combination with 6 months of androgen-deprivation therapy (ADT) with LHRH agonist or antagonist versus anti-androgen therapy (AAT) with apalutamide in patients with biochemical progression after radical prostatectomy
Not yet recruitingCTIS2024-512023-37-00
Target: 202Updated: 2025-09-11
A Randomized, open-label, Phase 2 Study of Adjuvant Apalutamide or Standard of Care in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy
Active, not recruitingCTIS2024-511832-29-00
Start: 2020-08-05Target: 190Updated: 2026-01-16
Phase 3
A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Active, not recruitingCTIS2022-502686-24-00
Start: 2023-11-22Target: 78Updated: 2025-09-10
A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy
Active, not recruitingCTIS2023-506153-38-00
Start: 2019-07-11Target: 668Updated: 2026-01-20
Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy
Active, not recruitingCTIS2023-505246-26-00
Start: 2016-01-27Target: 635Updated: 2025-12-16
A Phase 3 Randomized, Placebo-controlled Double-blind Study of JNJ-56021927 in Combination with Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Subjects with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)
Active, not recruitingCTIS2023-508606-26-00
Start: 2015-04-23Target: 5Updated: 2025-06-27
A Randomized, Controlled, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Adding Apalutamide to Radiotherapy and LHRH Agonist in High-Risk Patients With Hormone-Sensitive Prostate Cancer, Assessed by PSMA-PET, with an Observational Cohort
Active, not recruitingCTIS2023-505852-23-00
Start: 2020-11-12Target: 290Updated: 2025-07-21
A Phase 3 Randomized, Placebo-controlled, Double-blind Study of Apalutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Subjects with Metastatic Hormonesensitive Prostate Cancer (mHSPC)
Active, not recruitingCTIS2023-508607-20-00
Start: 2015-11-27Target: 7Updated: 2025-08-12
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Active, not recruitingCTIS2023-509221-47-00
Start: 2014-02-12Target: 30Updated: 2025-12-09
CARLHA-2_AN OPEN LABEL, RANDOMIZED, PHASE III STUDY EVALUATING THE EFFICACY OF ACOMBINATION OF APALUTAMIDE WITH RADIOTHERAPY AND LHRH AGONIST IN HIGH-RISK POST-PROSTATECTOMY BIOCHEMICALLY RELAPSED PROSTATE CANCER PATIENTS
Active, not recruitingCTIS2024-514829-36-00
Start: 2019-12-02Target: 429Updated: 2025-12-19