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A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy
Sponsor: Astellas Pharma Inc
Summary
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).
Official title: 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
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
52
Start Date
2018-09-19
Completion Date
2024-02-20
Last Updated
2026-06-24
Healthy Volunteers
No
Interventions
Enzalutamide
Enzalutamide was administered orally
Androgen deprivation therapy (ADT)
All participants were required to maintain ADT during study treatment, either using a Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or having a history of bilateral orchiectomy
Locations (8)
Site IN00002
Ahmedabad, India
Site IN00004
Hubli, India
Site IN00008
Kolkata, India
Site IN00003
Nashik, India
Site IN00007
Nashik, India
Site IN00010
New Delhi, India
Site IN00001
Pune, India
Site IN00011
Surat, India