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

NCT02489318

Active Not RecruitingPhase 3

Sponsor: Aragon Pharmaceuticals, Inc.

Conditions: Prostate Cancer

Interventions: Apalutamide, Placebo, Androgen Deprivation Therapy (ADT)

Countries: United States, Argentina, Australia, Brazil, Canada, China, Czechia, France

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 overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (220)

Homewood, Alabama, United States
Tucson, Arizona, United States
San Bernardino, California, United States
San Diego, California, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Fort Myers, Florida, United States
Chicago, Illinois, United States
Fort Wayne, Indiana, United States
Jeffersonville, Indiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Rockville, Maryland, United States
Lansing, Michigan, United States
Troy, Michigan, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Brooklyn, New York, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
The Bronx, New York, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Cleveland, Ohio, United States
Middleburg Heights, Ohio, United States
Springfield, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
Bryn Mawr, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
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