MedTrace Logo

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

NCT03523338 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-12-10

No results posted yet for this study

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

DRUG

Apalutamide

Participants will receive apalutamide 240 mg orally once daily.

DRUG

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.

Sponsors & Collaborators

  • Aragon Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Aragon Pharmaceuticals, Inc. Clinical Trial · Aragon Pharmaceuticals, Inc.

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil
  • Colombia
  • Mexico

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03523338 on ClinicalTrials.gov