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)
Radiographic Progression-free Survival (rPFS) — Up to 35 months rPFS as assessed by the investigator was defined as the duration from the date of randomization to the date of first documentation of radiographic progressive disease or death due to any cause, whichever occurred first. Radiographic progressive disease was defined as progression of soft tissue lesions measured by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by modified Response evaluation criteria in solid tumors (RECIST) 1.1.
Overall Survival (OS) — Up to 57 months OS was defined as the time from date of randomization to date of death from any cause.
Trial sites (220)
Facility
City
Region
Status
—
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
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.
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