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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-19

Study Completion Date

2024-02-20

Brief Summary

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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).

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Detailed Description

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Conditions

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Metastatic Castration Resistant Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enzalutamide

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.

Group Type EXPERIMENTAL

Enzalutamide

Intervention Type DRUG

Enzalutamide was administered orally

Androgen deprivation therapy (ADT)

Intervention Type 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

Interventions

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Enzalutamide

Enzalutamide was administered orally

Intervention Type DRUG

Androgen deprivation therapy (ADT)

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

Intervention Type DRUG

Other Intervention Names

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MDV3100 Xtandi

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No