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NCT02531516
An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
Conditions: Prostatic Neoplasms
Sex: Male
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1503
Sponsor: Aragon Pharmaceuticals, Inc.
Location: Homewood Alabama
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 Criteria
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 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 \
Source: ClinicalTrials.gov (NCT02531516). StuddyBuddy aggregates publicly available trial information.