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Clinical Trials in Canada / NCT02531516
Active, not recruiting Phase 3

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

NCT02531516 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2015-11-19
Last updated
2026-08-28

Condition(s) studied

Prostatic Neoplasms

Investigational drug(s) / intervention(s)

Apalutamide →Bicalutamide →Bicalutamide PlaceboApalutamide PlaceboGnRH (agonist) →74-80 Grays (units of radiation)

Study 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 (RT) results in an improvement of metastasis-free survival (MFS) based on conventional imaging assessed by blinded independent central review (BICR).

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (263)

FacilityCityRegionStatus
— Homewood Alabama
— Chandler Arizona
— Scottsdale Arizona
— Tucson Arizona
— Bakersfield California
— Los Angeles California
— Orange California
— San Bernardino California
— San Diego California
— San Francisco California
— Aurora Colorado
— Denver Colorado
— Middlebury Connecticut
— Bradenton Florida
— Daytona Beach Florida
— Fort Myers Florida
— Hialeah Florida
— Lakewood Rch Florida
— Naples Florida
— Plantation Florida
— Meridian Idaho
— Evergreen Park Illinois
— Harvey Illinois
— Jeffersonville Indiana
— Wichita Kansas
— Ashland Kentucky
— New Orleans Louisiana
— Shreveport Louisiana
— Scarborough Maine
— Baltimore Maryland
— Boston Massachusetts
— St Louis Missouri
— Morristown New Jersey
— Albany New York
— Brooklyn New York
— New York New York
— Poughkeepsie New York
— Rochester New York
— Syracuse New York
— The Bronx New York

+ 223 more sites — see the full list on the official registry below.

More Aragon Pharmaceuticals, Inc. trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02531516 on ClinicalTrials.gov ↗ ← All trials in Canada