Skip to main content
OpenTrials
Completed

NCT Number: 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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metastatic Castration Resistant Prostate Cancer

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Site IN00002, Ahmedabad, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Enzalutamide

Drug

Enzalutamide was administered orally

Other names: MDV3100, Xtandi

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

Primary outcomes

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

    Time frame: 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 after starting administration of the study drug.

Secondary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2018
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.