CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 52 enrolled / 52 target
Drug / intervention
Enzalutamide +1 moredrug
Likely dose
160 milligramsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03641560
NCT03641560Phase 4CompletedMonitor (0.6/mo)Completion was 28mo ago
CompareCT.gov

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

Astellas Pharma Inc·interventional·Posted Aug 22, 2018·Updated Jun 24, 2026

In Brief

A Phase 4 clinical trial evaluating Enzalutamide and Androgen deprivation therapy (ADT) for Metastatic Castration Resistant Prostate Cancer. Completed, enrolled 52 participants across 8 sites.

Signals

Enrolling slower than its timeline implies

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Castration Resistant Prostate Cancer
CountriesIndia
Collaborators--

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 22, 2018
Enrollment StartSep 19, 2018
Primary CompletionFeb 20, 2024
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 7.9 years ago

Arms & Interventions

Enzalutamideexperimental

Participants with progressive mCRPC who had previously been treated with docetaxel-based chemotherapy received 160 milligrams (mg) (4 capsules of 40 mg) enzalutamide orally, once daily until disease progression, unacceptable toxicity or any other discontinuation criteria were met.

Drug: EnzalutamideDrug: Androgen deprivation therapy (ADT)

Interventions

Enzalutamidedrug

Enzalutamide was administered orally

Androgen deprivation therapy (ADT)drug

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