An Expanded Access Protocol for Apalutamide Treatment of Participants With Non-Metastatic Castration-Resistant Prostate Cancer

NCT03523338 | Unknown

• 3 other identifiers: CR1084342017-004203-4156021927PCR3010
• Study Type: expanded_access
• Target: N/A
• Locations: 3 countries
• Sites: 12

Brief Summary

The purpose of this study is to collect additional safety data until apalutamide is commercially available for participants with non-metastatic castrate-resistant prostate cancer (NM-CRPC).

Conditions

Prostatic Neoplasms

Interventions

Apalutamide DRUG

Participants will receive apalutamide 240 mg orally once daily.

Also known as: JNJ-56021927

ADT (Standard of Care) DRUG

Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with confirmed prostate cancer, with evidence of castration resistance, with a rising prostate-specific antigen (PSA) while on androgen deprivation therapy (ADT), and for whom the treating physician believes additional therapy is indicated in the non-metastatic castrate-resistant prostate cancer (NM-CRPC) setting
• 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

You may not qualify if:

• Previously enrolled in another apalutamide study or eligible for enrollment in another ongoing clinical study of apalutamide
• 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)

Sponsors & Collaborators

• Aragon Pharmaceuticals, Inc.: lead

Study Sites (12)

Ynova Pesquisa Clinica

Florianópolis, 88020-210, Brazil

Location

Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)

Rio de Janeiro, 22775 001, Brazil

Location

Ensino e Terapia de Inovacao Clinica AMO Etica

Salvador, 41950 640, Brazil

Location

Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246 000, Brazil

Location

Fundacao Antonio Prudente A C Camargo Cancer Center

São Paulo, 01509 900, Brazil

Location

Núcleo de Pesquisa São Camilo

São Paulo, 04014-002, Brazil

Location

Hospital Pablo Tobon Uribe

Medellín, 050034, Colombia

Location

Instituto Nacional de Cancerologia

México, 14080, Mexico

Location

i Can Oncology Center

Monterrey, 64710, Mexico

Location

Oncologia Integral Satelite

Naucalpan, 53100, Mexico

Location

Centro Oncologico Estatal ISSEMYM

Toluca, 50180, Mexico

Location

Farmaco Oncología especializada S.A. de C.V

Zapopan, 45050, Mexico

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

apalutamide; Androgen Antagonists; Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Aragon Pharmaceuticals, Inc. Clinical Trial

  Aragon Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: May 14, 2018
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CO (1); ME (5); BR (6)