Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability
NCT ID: NCT02663193
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
108 participants
OBSERVATIONAL
2015-12-31
2017-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Enzalutamide Group
Participants who are receiving enzalutamide in a clinical practice setting will be observed for tolerability and quality of life.
No Intervention
Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
Abiraterone Acetate plus Prednisone group
Participants who are receiving abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
No Intervention
Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
Interventions
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No Intervention
Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
Eligibility Criteria
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Inclusion Criteria
* Have confirmed metastatic adenocarcinoma of the prostate
* Are starting treatment with enzalutamide or abiraterone acetate (with prednisone) for metastatic castration-resistant prostate cancer (mCRPC) at the full recommended dose per each drug's respective prescribing information (PI)
* Have an Eastern Cooperative Oncology Group Performance Status score of 0 or 1
* Sign written informed consent
Exclusion Criteria
* Have known mental illness including, but not limited to, major depressive disorder, general anxiety disorder, or bipolar disorder that, in the participating physician's opinion, could significantly confound the patient-reported outcome (PRO) assessments
* Have a history of or ongoing seizure disorder
* Have severe hepatic impairment (Child-Pugh Class C)
* Have an active infection (example, human immunodeficiency virus \[HIV\], viral hepatitis) or other medical condition that would contraindicate the use of prednisone/prednisolone (systemic glucocorticoid)
* Have known alcohol or other substance abuse disorder
* Are routinely taking medication-including, but not limited to, over-the-counter medications, supplements, medical marijuana or prescription pain medication-that is known to cause mental confusion or sedation or are using any of the medications
* Are routinely taking systemic glucocorticoids (example, prednisone, prednisolone, dexamethasone) at a dosage higher than the equivalent of prednisone 10 milligram (mg) daily
* Are currently using or have previously used chemotherapy for any cancer including mCRPC
* Are concurrently using any first-generation androgen-receptor blocker (example, bicalutamide, flutamide, nilutamide) for mCRPC
* Have previously taken enzalutamide or abiraterone acetate with prednisone
* Are not capable of completing tests using a computerized system or completing a participant survey
18 Years
MALE
No
Sponsors
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Janssen Scientific Affairs, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Scientific Affairs, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Scientific Affairs, LLC
Locations
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Homewood, Alabama, United States
La Mesa, California, United States
Wheat Ridge, Colorado, United States
Daytona Beach, Florida, United States
Indianapolis, Indiana, United States
Jeffersonville, Indiana, United States
Saint Clair Shores, Michigan, United States
Englewood, New Jersey, United States
Lawrenceville, New Jersey, United States
Morristown, New Jersey, United States
Poughkeepsie, New York, United States
Syracuse, New York, United States
Middleburg Heights, Ohio, United States
Springfield, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
Myrtle Beach, South Carolina, United States
San Antonio, Texas, United States
Virginia Beach, Virginia, United States
Countries
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Other Identifiers
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212082PCR4038
Identifier Type: OTHER
Identifier Source: secondary_id
CR108103
Identifier Type: -
Identifier Source: org_study_id
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