Clinical trial NCT02663193: Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability
Official title: A Multicenter, Two-arm, Prospective, Observational Study to Characterize the Tolerability of Treatment With Enzalutamide or Abiraterone Acetate (With Prednisone) for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Observational study
Enzalutamide
Abiraterone Acetate
Prednisone
Tolerability
Lead sponsor: Janssen Scientific Affairs, LLC
Sponsor class: INDUSTRY
First posted: 2016-01-26
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have a confirmed metastatic adenocarcinoma of the prostate will receive either enzalutamide or abiraterone acetate with prednisone for the treatment at the discretion of their treatment physician and in accordance with clinical practice.

Brief summary: The purpose of this study is to characterize the tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) -with specific focus on central nervous system (CNS) tolerability-and quality of life (QoL) after approximately 2 months of participants starting treatment with one of these agents for metastatic castration-resistant prostate cancer (mCRPC).

Detailed description: This is a multicenter (more than one study site), open-label (all people know the identity of the intervention), prospective, observational study to characterize the tolerability profile of treatment and quality of life (QoL) in participants receiving enzalutamide or abiraterone acetate (with prednisone) in a clinical practice setting. Approximately 100 male participants will be enrolled into this study, 50 participants will be recruited to each treatment arm. Participants will complete 2 scheduled on-site visits (Baseline and Month 2). Participants will primarily be observed for tolerability profiles of enzalutamide and abiraterone acetate (with prednisone) and safety over an observational period of 2 months.

Eligibility criteria: Inclusion Criteria:

* Male 18 years of age or older
* 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 a pre-existing central nervous system (CNS) condition (including, but not limited to, history of stroke or dementia) that, in the participating physician's judgment, would preclude participation in the study
* 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

Primary outcomes:
measure: Change From Baseline in Cogstate Tests at Month 2
timeFrame: Baseline and Month 2
measure: Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at Month 2
timeFrame: Baseline and Month 2
measure: Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-Fatigue) at Month 2
timeFrame: Baseline and Month 2
measure: Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at Month 2
timeFrame: Baseline and Month 2
measure: Participant or Caregiver Observational Questionnaire (Survey)
timeFrame: Baseline
measure: Participant or Caregiver Observational Questionnaire (Survey)
timeFrame: Month 2
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Serious AEs
timeFrame: Screening up to follow-up (Approximately 2 Months)
Other outcomes:
Locations:
city: Homewood
country: United States
state: Alabama
city: La Mesa
country: United States
state: California
city: Wheat Ridge
country: United States
state: Colorado
city: Daytona Beach
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Jeffersonville
country: United States
state: Indiana
city: Saint Clair Shores
country: United States
state: Michigan
city: Englewood
country: United States
state: New Jersey
city: Lawrenceville
country: United States
state: New Jersey
city: Morristown
country: United States
state: New Jersey
city: Poughkeepsie
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Middleburg Heights
country: United States
state: Ohio
city: Springfield
country: United States
state: Oregon
city: Bala-Cynwyd
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Virginia Beach
country: United States
state: Virginia
Study officials:
affiliation: Janssen Scientific Affairs, LLC
name: Janssen Scientific Affairs, LLC Clinical Trial
role: STUDY_DIRECTOR
References: