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

• Status: Active, not recruiting
• Trial end date: 2022-11-30
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Androgens; Docetaxel

Criteria

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.