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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT02489318

Run by

Aragon Pharmaceuticals, Inc.

People needed

1052

Starts

2015-11-27

Expected to finish

2027-12-31

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — San Bernardino, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Norwalk, Connecticut, United States
• Study site — Fort Myers, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Jeffersonville, Indiana, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Baltimore, Maryland, United States
• Study site — Rockville, Maryland, United States
• Study site — Lansing, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Brooklyn, New York, United States
• Study site — Poughkeepsie, New York, United States
• Study site — Syracuse, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Salisbury, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Middleburg Heights, Ohio, United States
• Study site — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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