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COMPLETED
NCT03641560
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

Enzalutamide

Enzalutamide was administered orally

DRUG

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