For Healthcare Professionals

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

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About the study

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).
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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

EXCLUSION CRITERIA

Exclusion Criteria:


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

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition

Metastatic Castration Resistant Prostate Cancer

Age (in years)

18+

Phase

Phase 4

Participants needed

52

Est. Completion Date

Nov 30, 2024

Treatment type

Interventional


Sponsor

Astellas Pharma Inc

ClinicalTrials.gov identifier

NCT03641560

Study number

9785-CL-0413

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