ATLAS 56021927PCR3003

Study StatusEnrolling
Study Description

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of JNJ-56021927 in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment with Primary Radiation Therapy

Primary Endpoint

To determine if JNJ-56021927 plus GnRH agonist in subjects with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival evaluated by blinded independent central review

Inclusion Criteria

-Subject must be a man age ≥ 18 years of age
-Able to sign informed consent
-Indicated and planned to receive primary RT for prostate cancer
-Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis:
-Gleason score ≥8 and ≥cT2c
-Gleason score ≥7, PSA ≥20 ng/ml, and ≥cT2c
-Charson comorbidity index (CCI) ≤3
-ECOG performance status grade of 0 or 1
-Adequate liver function determined by the following central lab values:
-AST, ALT <2 x ULN, total bilirubin <1.5 x ULN (except if have Gilbert’s
-Subjects must use a condom during sexual activity while on study drug and for 3 months following the last dose of study drug. Donation of sperm is not allowed during the treatment phase and for 3 months following the last dose of study drug.
-Be able to swallow whole study drug tablet

Exclusion Criteria

-Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis
-Prior treatment with GnRH analogue or anti-androgen or both for >3 months prior to randomization
-Bilateral orchiectomy
-History of pelvic radiation
-Prior systemic or procedural treatment for prostate cancer
-Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestiational agents for prostate cancer
-Prior treatment with radiopharmaceutical agents or immunotherapy for prostate cancer
-Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
-Use of 5-a reductase inhibitors (dutasteride, finasteride) ≤4 weeks prior to randomization
-Use of any investigational agent ≤4 weeks prior to randomization
-Current chronic use of opioid analgesics for ≥3 weeks for oral or ≥7 days for non-oral formulations
-Major surgery ≤4 weeks prior to randomization
-Hx of seizure or condition that may predispose to seizure (stroke, TIA or loss of consciousness ≤1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
-Current or prior treatment with anti-epileptic medications for the treatment of seizures
-GI conditions affecting absorption
-known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations

Side Effects

-Swelling face, arms, hands, lower legs, or feet, hematuria, blurred vision, body aches or pain, congestion, productive cough, labored breathing, dizziness, sore throat, fever or chills, headache, nervousness, jaundice, nausea

-Fatigue, diarrhea, nausea, skin rash, abdominal pain, changes in thyroid function, constipation, itching, dizziness, hot flashes, insomnia, tremors

Interested in enrolling in this trial? Please call 717-431-2285.

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