A 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 Inc52 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Castration Resistant Prostate Cancer

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (8)

Site IN00002

Ahmedabad, India

Site IN00004

Hubli, India

Site IN00008

Kolkata, India

Site IN00003

Nashik, India

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

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.

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)

Data from ClinicalTrials.gov

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