A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

A Multicenter Phase 4, Open-label, Single-arm, Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

The purpose of this study was to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study also evaluated the effect of enzalutamide on prostate-specific antigen (PSA).

Inclusion Criteria:

• Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
• Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
• Subject is being newly initiated on Xtandi treatment (Enzalutamide).
• Subject has an estimated life expectancy of ≥ 6 months.
• Subject agrees not to participate in another interventional study while participating in the present study.

Exclusion Criteria:

• Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
• Subject participating or planning to participate in any interventional drug trial during the course of this trial.
• Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Subject has any condition which makes the subject unsuitable for study participation.