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 Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and tolerability of enzalutamide in Indian patients with progressive mCRPC previously treated with docetaxel-based chemotherapy. This study will also evaluate the effect of enzalutamide on prostate-specific antigen (PSA).

Official Title
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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

Conditions
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Metastatic Castration Resistant Prostate Cancer

Intervention / Treatment
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* Drug: Enzalutamide
* Drug: Androgen deprivation therapy (ADT)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enzalutamide group<br>Participants will receive Enzalutamide once daily in addition to continued androgen deprivation therapy until discontinuation criteria is met | Drug: Enzalutamide<br>* Enzalutamide will be administered orally<br>* Other names: Xtandi;Drug: Androgen deprivation therapy (ADT)<br>* All participants will be required to maintain ADT during study treatment, either using a Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or having a history of bilateral orchiectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by incidence of adverse events (AEs) | An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) guidelines (Version 4.03). | Up to 10 months | 
| Number of participants with laboratory test abnormalities and/or AEs | Number of participants with potentially clinically significant laboratory values. | Up to 10 months | 
| Number of participants with physical examination abnormalities and/or AEs | Number of participants with potentially clinically significant physical examination values. | Up to 10 months | 
| Number of participants with vital sign abnormalities and/or AEs | Number of participants with potentially clinically significant vital sign values. | Up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy assessed by prostate-specific antigen (PSA) response rate (≥ 50% reduction from baseline) | PSA response ≥ 50% is defined as ≥ 50% reductions in PSA level from baseline to the lowest post-baseline PSA result as determined by the central laboratory, with a consecutive assessment conducted at least 3 weeks later to confirm the PSA response. | Up to 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Progressive Metastatic Castration-Resistant Prostate Cancer (mCRPC), Enzalutamide, Xtandi, MDV3100