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NCT01946204 · ClinicalTrials.gov registry record · Phase 3

A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer

A Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
1,207
Enrollment target
20
Study locations

NCT01946204: Active Phase 3 study of Prostatic Neoplasms, sponsored by Aragon Pharmaceuticals.

NCT01946204 is a Phase 3 study of Prostatic Neoplasms that is active but no longer recruiting, run by Aragon Pharmaceuticals. The registered enrollment target is 1,207 participants, above the 496-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (143% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01946204, a Phase 3 study of Prostatic Neoplasms, is active but no longer recruiting, sponsored by Aragon Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
1,207 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

Primary Outcome

MFS was defined as the time from randomization to the time of first evidence of BICR-confirmed bone or soft tissue distant metastasis or death due to any cause, whichever occurred first. The MFS data for participants without metastasis or death were performed for US or ex-US regulatory purposes. Radiographic scans (bone scans and computerized tomography \[CT\] or magnetic resonance imaging \[MRI\] of the chest, abdomen, and pelvis) were performed for detection of metastasis throughout the study.

Conditions Studied

Prostatic Neoplasms

Interventions

  • DRUG Placebo
  • DRUG Apalutamide

Study Locations (20)

California

  • - Duarte
  • - Fullerton
  • - Laguna Woods
  • - Los Angeles
  • - Orange
  • - Roseville
  • - Sacramento
  • - San Bernardino
  • - San Diego
  • - San Francisco
  • - Santa Monica
  • - Sherman Oaks
  • - Stanford
  • - Tarzana
  • - Torrance

Arizona

  • - Chandler
  • - Tucson

Alabama

  • - Birmingham

Alaska

  • - Anchorage

Colorado

  • - Denver

Trial Details

FieldValue
Enrollment Target 1,207 participants
Start Date 2013-10-14
Est. Completion 2027-12-31
Phase Phase 3
Aragon Pharmaceuticals

12 total trials

What the registry record for NCT01946204 still lists

NCT01946204 is an interventional study that assigns participants to a tested intervention. Its 1,207 participants enrollment target places it among the larger protocols in the corpus, above the 496-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (143% higher).

The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01946204 names 20 study sites across 5 states, led by California, Arizona, Alabama.

Frequently Asked Questions

What is clinical trial NCT01946204 about?

NCT01946204 is a clinical study titled "A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer". The purpose of this study is to evaluate the efficacy and safety of apalutamide in adult men with high-risk non-metastatic castration-resistant prostate cancer.

What is the current status of trial NCT01946204?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,207 participants. The study started on 2013-10-14. Estimated completion is 2027-12-31.

What conditions does trial NCT01946204 study?

This clinical trial studies the following conditions: Prostatic Neoplasms.

What interventions are being tested in trial NCT01946204?

The interventions under investigation include: Placebo (DRUG), Apalutamide (DRUG).

Who is sponsoring clinical trial NCT01946204?

This trial is sponsored by Aragon Pharmaceuticals, which has 12 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01946204 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Prostatic Neoplasms

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01946204's enrollment target sits among peer trials

1,207 9th of 65 higher than 57 of 65 other Prostatic Neoplasms trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT01946204, the US trial registry maintained by the National Library of Medicine. NCT01946204 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.