Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT02663193
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.
Study:
NCT02663193
Study Brief:
Protocol Section:
NCT02663193