Trials / Completed
CompletedNCT03641560
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
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-09-19
- Primary completion
- 2024-02-20
- Completion
- 2024-02-20
- First posted
- 2018-08-22
- Last updated
- 2025-04-08
- Results posted
- 2025-01-23
Locations
8 sites across 1 country: India
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03641560. Inclusion in this directory is not an endorsement.