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).
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.
Study Type
OBSERVATIONAL
Enrollment
108
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.
Unnamed facility
Homewood, Alabama, United States
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La Mesa, California, United States
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Change From Baseline in Cogstate Tests at Month 2
The Cogstate computerized cognitive test battery will be used as the assessment tool in this study. Overall, Cogstate measures a range of cognitive functions (example, psychomotor and memory function) using a number of different tests (example, choice reaction time, one-back memory). This battery of tests was chosen because it has been shown to be sensitive to very small cognitive changes and has been tested in cancer participants after chemotherapy.
Time frame: Baseline and Month 2
Change From Baseline in European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 at Month 2
The EORTC QLQ-C30 is a questionnaire developed to assess the quality of Life (QoL) of cancer participants. The QLQ-C30 incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 3 symptom scales (fatigue, pain, and nausea and vomiting); and a global health and QoL scale.
Time frame: Baseline and Month 2
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue subscale (FACIT-Fatigue) at Month 2
The FACIT Measurement System is a collection of health-related QoL questionnaires targeted to the management of chronic illness. The fatigue subscale (FACIT-Fatigue) is a validated, 13-item questionnaire that assesses fatigue in people being treated for a chronic illness.
Time frame: Baseline and Month 2
Change From Baseline in Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) at Month 2
The FACT-Cog is a validated, 37-item, subjective neuropsychological instrument designed to evaluate cancer participants perceived cognitive deterioration on their quality of life.
Time frame: Baseline and Month 2
Participant or Caregiver Observational Questionnaire (Survey)
If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
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Wheat Ridge, Colorado, United States
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Daytona Beach, Florida, United States
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Indianapolis, Indiana, United States
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Jeffersonville, Indiana, United States
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Saint Clair Shores, Michigan, United States
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Englewood, New Jersey, United States
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Lawrenceville, New Jersey, United States
Unnamed facility
Morristown, New Jersey, United States
...and 10 more locations
Time frame: Baseline
Participant or Caregiver Observational Questionnaire (Survey)
If a participant has a regular caregiver, the participating physician will ask the caregiver to complete an optional observational, sponsor-developed questionnaire (survey) pertaining to his/her perception of the participants tolerability of treatment and QoL.
Time frame: Month 2
Number of Participants with Adverse Events (AEs) and Serious AEs
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Screening up to follow-up (Approximately 2 Months)