ATLAS: A Randomized, Double-blind, Placebo-controlled Phase III Study of JNJ-56021927 in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer Receiving Treatment With Primary Radiation Therapy
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Study Summary
To determine if JNJ-56021927 plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy results in an improvement of metastasis-free survival (MFS) evaluated by blinded independent central review (BICR)
To evaluate the efficacy of apalutamide in patients with high-risk localized or locally advanced prostate cancer (Gleason score of > or = 8 and > or = cT2c or a Gleason score of > or = 7 and prostate-specific antigen > or = 20 ng/mL and > or = cT2c) receiving primary RT.
Imaging with CT or MRI and bone scan will be conducted at baseline and then every 6 months following biochemical failure until documented distant metastasis by blinded-to-arm independent central review or death.
To investigate whether treatment intensification with the addition of APA to neoadjuvant and adjuvant treatment with gonadotropin-releasing hormone agonist (GnRHa) and external beam radiation therapy (EBRT) will improve metastasis-free survival (MFS) in high-risk pts.
To determine MFS improvement, long-term patient retention and physician engagement are critical
- Age > or = 18 years
- Indicated and planned to receive primary radiation therapy for prostate cancer
- Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score > or =8 and > or =cT2c, 2) Gleason score > or =7, PSA > or =20 nanogram per milliliters (ng/mL), and > or =cT2c
- Charlson index (CCI) < or =3
- An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
- Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (<) 1.5 milligram/deciliter (mg/dL) (<133 micromoles/Liter [mcmol/L]), (3) platelets greater than or equal to (> or =)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin > or = 12.0 gram/deciliter (g/dL) (7.4 millimloes [mmol], independent of transfusion and/or growth factors within 3 months prior to randomization
- Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
- Signed, written, informed consent
- Be able to swallow whole study drug tablets
- Presence of distant metastasis, including pelvic nodal disease below the iliac bifurcation >2 cm in the short axis
- Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for >3 months prior to randomization
- Bilateral orchiectomy
- History of pelvic radiation
- Prior systemic (example [e.g.], chemotherapy) or procedural (e.g., prostatectomy, cryotherapy) treatment for prostate cancer
- History of seizure or condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness < or = 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
- Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents for prostate cancer
- Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
- Prior treatment with systemic glucocorticoids < or =4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
- Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) < or =4 weeks prior to randomization
- Use of any investigational agent < or =4 weeks prior to randomization
- Current chronic use of opioid analgesics for >or =3 weeks for oral or >7 days for non-oral formulations
- Major surgery < or =4 weeks prior to randomization
- Current or prior treatment with anti-epileptic medications for the treatment of seizures
- Gastrointestinal conditions affecting absorption
- Known or suspected contraindications or hypersensitivity to JNJ-56021927, bicalutamide or GnRH agonists or any of the components of the formulations
- Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject
Clinical Study Information for Healthcare Providers
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