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Clinical Trials in the UK / NCT02489318
Active, not recruiting Phase 3

A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC

NCT02489318 · tracked via the Priya Life Science UK tracker
Sponsor
Aragon Pharmaceuticals, Inc.
Phase
Phase 3
Started
2015-11-27
Last updated
2026-08-31

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

ApalutamidePlaceboAndrogen Deprivation Therapy (ADT)

Apalutamide: Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.

Placebo: Participants will receive Placebo orally once daily in each 28 day treatment cycles.

Androgen Deprivation Therapy (ADT): All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog \[GnRHa\] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Study summary

The purpose of this study is to determine if the addition of apalutamide to ADT provides superior efficacy in improving radiographic progression-free survival (rPFS) or overall survival (OS) for participants with mHSPC.

Eligibility

Sex
MALE
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of prostate adenocarcinoma as confirmed by the investigator * Metastatic disease documented by greater than or equal to (\>=) 1 bone lesions on 99mTc bone scan. Participants with a single bone lesion must have confirmation of bone metastasis by computed tomography (CT) or magnetic resonance imaging (MRI) * Eastern Cooperative Oncology Group Performance Status (ECOG PS) grade of 0 or 1 * Participants who received docetaxel treatment must meet the following criteria: a) Received a maximum of 6 cycles of docetaxel therapy for mHSPC; b) Received the last dose of docetaxel \<=2 months prior to randomization; c) Maintained a response to docetaxel of stable disease or better, by investigator assessment of imaging and PSA, prior to randomization * Other allowed prior treatment for mHSPC: a) Maximum of 1 course of radiation or surgical intervention; radiation therapy for metastatic lesions must be completed prior to randomization; b) Less than or equal to (\<=) 6 months of ADT prior to randomization * Allowed prior treatments for localized prostate cancer (all treatments must have been completed \>= 1 year prior to randomization) a) \<= 3 years total of ADT; b) All other forms of prior therapies including radiation therapy, prostatectomy,lymph node dissection, and systemic therapies Exclusion Criteria: * Pathological finding consistent with small cell, ductal or neuroendocrine carcinoma of the prostate * Known brain metastases * Lymph nodes as only sites of metastases * Visceral (ie, liver or lung) metastases as only sites of metastases * Other prior malignancy less than or equal to 5 years prior to randomization with the exception of squamous or basal cell skin carcinoma or non-invasive superficial bladder cancer * Prior treatment with other next generation anti-androgens or other CYP17 inhibitors, immunotherapy or radiopharmaceutical agents for prostate cancer * History of seizures or medications known to lower seizure threshold

Primary outcome measure(s)

Trial sites (220)

FacilityCityRegionStatus
Homewood Alabama
Tucson Arizona
San Bernardino California
San Diego California
Denver Colorado
Norwalk Connecticut
Fort Myers Florida
Chicago Illinois
Fort Wayne Indiana
Jeffersonville Indiana
New Orleans Louisiana
Baltimore Maryland
Rockville Maryland
Lansing Michigan
Troy Michigan
Omaha Nebraska
Las Vegas Nevada
Brooklyn New York
Poughkeepsie New York
Syracuse New York
The Bronx New York
Raleigh North Carolina
Salisbury North Carolina
Cleveland Ohio
Middleburg Heights Ohio
Springfield Oregon
Bala-Cynwyd Pennsylvania
Bryn Mawr Pennsylvania
Lancaster Pennsylvania
Charleston South Carolina
Nashville Tennessee
Dallas Texas
Houston Texas
San Antonio Texas
Richmond Virginia
Virginia Beach Virginia
Burien Washington
Spokane Washington
Milwaukee Wisconsin
Berazategui Argentina

+ 180 more sites — see the full list on the official registry below.

More Aragon Pharmaceuticals, Inc. trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02489318 on ClinicalTrials.gov ↗ ← All trials in the UK