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

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

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).

Study Overview

• Status: No longer available
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Apalutamide; Drug: ADT (Standard of Care)

• Study Type: Expanded Access
• Expanded Access Type: Intermediate-size Population

Contacts and Locations

Study Locations

• Brazil
  • Florianópolis, Brazil, 88020-210
    • Ynova Pesquisa Clinica
  • Rio de Janeiro, Brazil, 22775 001
    • Instituto de Educacao, Pesquisa e Gestao em Saude Instituto Americas (COI)
  • Salvador, Brazil, 41950 640
    • Ensino E Terapia de Inovacao Clinica Amo Etica
  • São Paulo, Brazil, 04014-002
    • Núcleo de Pesquisa São Camilo
  • São Paulo, Brazil, 01509 900
    • Fundacao Antonio Prudente A C Camargo Cancer Center
  • São Paulo, Brazil, 01246 000
    • Fundacao Faculdade de Medicina - Instituto do Cancer do Estado de Sao Paulo
• Colombia
  • Medellín, Colombia, 050034
    • Hospital Pablo Tobon Uribe
• Mexico
  • Monterrey, Mexico, 64710
    • i Can Oncology Center
  • México, Mexico, 14080
    • Instituto Nacional de Cancerologia
  • Naucalpan, Mexico, 53100
    • Oncología Integral Satélite
  • Toluca, Mexico, 50180
    • Centro Oncológico Estatal ISSEMYM
  • Zapopan, Mexico, 45050
    • Farmaco Oncología especializada S.A. de C.V

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Aragon Pharmaceuticals, Inc.
• Investigators: Study Director: Aragon Pharmaceuticals, Inc. Clinical Trial, Aragon Pharmaceuticals, Inc.

Study record dates

Study Registration Dates

• First Submitted: May 1, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Estimated): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 4, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Health Services Administration; Health Care Quality, Access, and Evaluation; Pharmacologic Actions; Chemical Actions and Uses; Quality of Health Care; Quality Indicators, Health Care; Androgen Antagonists; Standard of Care; apalutamide
• Other Study ID Numbers: CR108434; 2017-004203-41 (EudraCT Number); 56021927PCR3010 (Other Identifier: Aragon Pharmaceuticals, Inc.)