An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer
NCT ID: NCT03523338
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NO_LONGER_AVAILABLE
EXPANDED_ACCESS
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Pharmacokinetic and Proof-of-Concept Study of ARN-509 (Apalutamide) in Castration-Resistant Prostate Cancer (CRPC)
NCT01171898
Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer
NCT05534646
A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
NCT01946204
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)
NCT02257736
A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
NCT03767244
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Apalutamide
Participants will receive apalutamide 240 mg orally once daily.
ADT (Standard of Care)
Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
a) Willingness to continue gonadotropin releasing hormone analog (GnRHa) throughout study if the participant is medically castrated
* Must sign an informed consent form (ICF) (or the participant's legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
* To avoid risk of drug exposure through the ejaculate (even participants with vasectomies), participants must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed while on study drug and for 3 months following the last dose of study drug
* Willingness and ability to comply with prohibitions and restrictions specified in this protocol, scheduled visits, treatment plans, laboratory, and other study procedures, including ability to swallow study drug tablets
Exclusion Criteria
* Enrolled in another interventional clinical study of anti-neoplastic agents
* Ongoing grade greater than (\>) 1 acute toxicity due to prior therapy or surgical procedure
* Concurrent therapy with medications known to lower the seizure threshold must have been discontinued or substituted at least 4 weeks prior to study entry
* Current or prior treatment with anti-epileptic medications for the treatment of seizures. History of seizure or condition that may predispose to seizure (including, but not limited to prior cerebrovascular accident, transient ischemic attack, or loss of consciousness within 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as a schwannoma or meningioma that is causing edema or mass effect)
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aragon Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Aragon Pharmaceuticals, Inc. Clinical Trial
Role: STUDY_DIRECTOR
Aragon Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ynova Pesquisa Clinica
Florianópolis, , Brazil
Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
Rio de Janeiro, , Brazil
Ensino e Terapia de Inovacao Clinica AMO Etica
Salvador, , Brazil
Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
São Paulo, , Brazil
Fundacao Antonio Prudente A C Camargo Cancer Center
São Paulo, , Brazil
Núcleo de Pesquisa São Camilo
São Paulo, , Brazil
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Instituto Nacional de Cancerologia
México, , Mexico
i Can Oncology Center
Monterrey, , Mexico
Oncologia Integral Satelite
Naucalpan, , Mexico
Centro Oncologico Estatal ISSEMYM
Toluca, , Mexico
Farmaco Oncología especializada S.A. de C.V
Zapopan, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-004203-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
56021927PCR3010
Identifier Type: OTHER
Identifier Source: secondary_id
CR108434
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.