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Summary

for males ages 18 years and up
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Prostatic Neoplasms Prostate Cancer High-Risk prostate cancer JNJ-56021927 Apalutamide ATLAS Radiation Long-term hormone therapy Localized or locally advanced prostate cancer Janssen Hormones Bicalutamide

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

-

  • 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

Locations

  • California Pacific Medical Center completed
    San Francisco, California, 94115, United States
  • CBCC Global Research completed
    Bakersfield, California, 93309, United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles, California, 90048, United States
  • Tower Urology accepting new patients
    Los Angeles, California, 90048, United States
  • VA West Los Angeles Medical Center terminated
    Los Angeles, California, 90073, United States
  • San Bernardino Urological Associates accepting new patients
    San Bernardino, California, 92404, United States
  • University of California, Irvine accepting new patients
    Orange, California, 92868, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Aragon Pharmaceuticals, Inc.
Links
To learn how to participate in this trial please click here.
ID
NCT02531516
Phase
Phase 3
Study Type
Interventional
Last Updated
July 1, 2017
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