An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS



Status:Active, not recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:November 19, 2015
End Date:October 6, 2026

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ATLAS: 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

The purpose of this study is to determine if apalutamide 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.

This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus
GnRH agonist compared with GnRH agonist among participants with high-risk, localized or
locally advanced prostate cancer receiving primary radiation therapy (RT). The study will
include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up
Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50
milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the
study.

Inclusion Criteria:

- Age >= 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 >=8 and >=cT2c, 2) Gleason score >=7, PSA >=20 nanogram
per milliliters (ng/mL), and >=cT2c

- Charlson index (CCI) <=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 (>=)140,000/microLiter (mcL), independent of transfusion
and/or growth factors within 3 months prior to randomization, (4) Hemoglobin >= 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

Exclusion Criteria: -

- Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease
below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of
distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal
disease (clinical N stage; N1 versus N0) will be assessed by central radiological
review. Patients are considered eligible only if the central radiological review
confirms clinical stage M0.

- 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 local (e.g. radical prostatectomy,
cryotherapy) treatment for prostate cancer

- History of seizure or any condition that may predispose to seizure (including, but not
limited to prior stroke, transient ischemic attack 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)

- Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone,
ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational
agents (including cyproterone acetate) 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 ≤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) <=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

- Current or prior treatment with anti-epileptic medications for the treatment of
seizures

- Gastrointestinal conditions affecting absorption

- Known or suspected contraindications or hypersensitivity to apalutamide, 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
We found this trial at
62
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