NCT03641560

A Safety and Efficacy Study of Enzalutamide in Indian Patients With Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC) Previously Treated With Docetaxel-Based Chemotherapy

Completed Phase 4 Results posted Last updated 8 April 2025

What this trial tests

Phase 4 trial testing Enzalutamide in Metastatic Castration Resistant Prostate Cancer in 52 participants. Completed in 20 February 2024.

Timeline

19 September 2018

Primary endpoint
20 February 2024

20 February 2024

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	19 September 2018
Primary completion	20 February 2024
Estimated completion	20 February 2024
Sites	8 locations across India

Drugs / interventions tested

• Enzalutamide (enzalutamide) — full drug profile →
• Androgen deprivation therapy (ADT) — full drug profile →

Conditions studied

• Metastatic Castration Resistant Prostate Cancer — all drugs for Metastatic Castration Resistant Prostate Cancer →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

18 and older, male only, with Metastatic Castration Resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment- Emergent Adverse Events (TEAEs) Primary · From first dose of study drug until 30 days after last dose (Up to 1899 days)

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding \[e.g. hematology, clinical chemistry, or urinalysis or other safety assessment e.g., ECGs, radiographic scans, vital signs measurements, physical examination\]), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. TEAE was defined as an adverse event observed

Group	Value	95% CI
Enzalutamide	36

Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response Secondary · Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899)

Confirmed PSA response rate was defined as the percentage of participants with \>= 50% decline in PSA from baseline to the lowest postbaseline PSA result, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response.

Group	Value	95% CI
Enzalutamide	46

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug until 30 days after last dose (Up to 1899 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Enzalutamide

Serious: 10/52 (19%)

Deaths: 6/52

Serious adverse events (14 terms)

Reaction	System	Enzalutamide
Respiratory failure	Respiratory, thoracic and mediastinal disorders	—
Cardiac arrest	Cardiac disorders	—
Cardio-respiratory arrest	Cardiac disorders	—
Myocardial ischaemia	Cardiac disorders	—
Asthenia	General disorders	—
Chest discomfort	General disorders	—
Multiple organ dysfunction syndrome	General disorders	—
Lower respiratory tract infection	Infections and infestations	—
Pneumonia	Infections and infestations	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Hypoxic-ischaemic encephalopathy	Nervous system disorders	—
Haematuria	Renal and urinary disorders	—
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	—
Hypotension	Vascular disorders	—

Other adverse events (9 terms — click to expand)

Reaction	System	Enzalutamide
Constipation	Gastrointestinal disorders	—
Pain	General disorders	—
Decreased appetite	Metabolism and nutrition disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Asthenia	General disorders	—
Nausea	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: Respiratory failure, Cardiac arrest, Cardio-respiratory arrest, Myocardial ischaemia, Asthenia, Chest discomfort, Multiple organ dysfunction syndrome, Lower respiratory tract infection.

Data from ClinicalTrials.gov NCT03641560 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Abiraterone, Orteronel, Enzalutamide and Docetaxel: Sequential or Combined Therapy?
   Chen MK, Liang ZJ, Luo DS, Xue KY, et al · · 2022 · cited 11× · PMID 35250590 · DOI 10.3389/fphar.2022.843110