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New drug made available early for men with advanced prostate cancer

NCT ID NCT03523338

Disease control Sponsor: Aragon Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended) This study
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study provides early access to apalutamide for men whose prostate cancer has stopped responding to standard hormone therapy but has not yet spread. The goal is to gather more safety information while offering treatment before the drug is widely available. Participants must continue hormone therapy and have a rising PSA level.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostatic neoplasms

Contacts and locations

Locations

  • Centro Oncologico Estatal ISSEMYM

    Toluca, 50180, Mexico

  • Ensino e Terapia de Inovacao Clinica AMO Etica

    Salvador, 41950 640, Brazil

  • Farmaco Oncología especializada S.A. de C.V

    Zapopan, 45050, Mexico

  • Fundacao Antonio Prudente A C Camargo Cancer Center

    São Paulo, 01509 900, Brazil

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

    São Paulo, 01246 000, Brazil

  • Hospital Pablo Tobon Uribe

    Medellín, 050034, Colombia

  • Instituto Nacional de Cancerologia

    México, 14080, Mexico

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

    Rio de Janeiro, 22775 001, Brazil

  • Núcleo de Pesquisa São Camilo

    São Paulo, 04014-002, Brazil

  • Oncologia Integral Satelite

    Naucalpan, 53100, Mexico

  • Ynova Pesquisa Clinica

    Florianópolis, 88020-210, Brazil

  • i Can Oncology Center

    Monterrey, 64710, Mexico

More trials for these conditions

Other studies related to the condition(s) this trial covers.