Clinical trial · Observational
Real-World Study of Enzalutamide and Abiraterone Acetate (With Prednisone) Tolerability
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)
NCT02663193CI-TRIAL-00085432REAAcTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Enzalutamide Group
- description
- Participants who are receiving enzalutamide in a clinical practice setting will be observed for tolerability and quality of life.
- interventionNames
- Other: No Intervention
- label
- Abiraterone Acetate plus Prednisone group
- description
- Participants who are receiving abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
- interventionNames
- Other: No Intervention
Primary outcomes (6)
- measure
- Change From Baseline in Cogstate Tests at Month 2
- timeFrame
- Baseline and Month 2
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.