ATLAS 56021927PCR3003

Study StatusEnrolling
ProtocolJanssen
Sponsor
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
Syndrome)
-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

Bicalutamide
-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

JNJ
-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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