A Study of Apalutamide (JNJ-56021927, ARN-509) Plus Androgen Deprivation Therapy (ADT) Versus ADT in Participants With mHSPC
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Apalutamide; Placebo; Androgen Deprivation Therapy (ADT)
Intervention description: Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.; Participants will receive Placebo orally once daily in each 28 day treatment cycles.; 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.
Intervention MeSH terms: Androgens
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1052.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer; JNJ-56021927; Androgen Deprivation Therapy; ARN-509; Apalutamide; TITAN; Metastatic Hormone-sensitive Prostate Cancer

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 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