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

NCT03641560 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 9785-CL-0413
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 8

Brief 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

Metastatic Castration Resistant Prostate Cancer

Keywords

Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC); Enzalutamide; Xtandi; MDV3100

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment- Emergent Adverse Events (TEAEs)

  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 after starting administration of the study drug.

  From first dose of study drug until 30 days after last dose (Up to 1899 days)

Secondary Outcomes (1)

• Percentage of Participants With Confirmed Prostate-specific Antigen (PSA) Response

  Baseline (Day 1); Days 29, 57, 85, 169 and then every 84 days until 30 days after the last dose (up to Day 1899)

Study Arms (1)

Enzalutamide

EXPERIMENTAL

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: Enzalutamide; Drug: Androgen deprivation therapy (ADT)

Interventions

Enzalutamide DRUG

Enzalutamide was administered orally

Also known as: MDV3100, Xtandi

Enzalutamide

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

Enzalutamide

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology.
• Subject with established diagnosis of metastatic castration-resistant prostate carcinoma.
• Subject is being newly initiated on Xtandi treatment (Enzalutamide).
• Subject has an estimated life expectancy of ≥ 6 months.
• Subject agrees not to participate in another interventional study while participating in the present study.

You may not qualify if:

• Subject who is not eligible to receive Xtandi as per the locally approved prescribing information.
• Subject participating or planning to participate in any interventional drug trial during the course of this trial.
• Subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening.
• Subject has any condition which makes the subject unsuitable for study participation.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (8)

Site IN00002

Ahmedabad, India

Location

Site IN00004

Hubli, India

Location

Site IN00008

Kolkata, India

Location

Site IN00003

Nashik, India

Location

Site IN00007

Nashik, India

Location

Site IN00010

New Delhi, India

Location

Site IN00001

Pune, India

Location

Site IN00011

Surat, India

Location

Related Links

• Link to results and other applicable study documents on the Astellas Clinical Trials website
• Link to plain language summary of the study on the Trial Results Summaries website

MeSH Terms

Interventions

enzalutamide; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Results Point of Contact

• Title: Clinical Transparency
• Organization: Astellas Global Development, Inc. (APGD)

astellas.resultsdisclosure@astellas.com

800-888-7704

Study Officials

• Central Contact

  Astellas Pharma Inc

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 19, 2018
• Primary Completion: February 20, 2024
• Study Completion: February 20, 2024
• Last Updated: April 8, 2025
• Results First Posted: January 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

Locations

IN (8)