A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
About the study
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).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION 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
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.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Metastatic Castration Resistant Prostate Cancer
Age (in years)
18+
Phase
Phase 4
Participants needed
52
Est. Completion Date
Nov 30, 2024
Treatment type
Interventional
Sponsor
Astellas Pharma Inc
ClinicalTrials.gov identifier
NCT03641560
Study number
9785-CL-0413
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