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

Metastatic Castration Resistant Prostate Cancer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641560
• Other study ID #: 9785-CL-0413
• Status: Completed
• Phase: Phase 4
• Start date: September 19, 2018
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 20, 2024
• Est. primary completion date: February 20, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Enzalutamide
Enzalutamide will be administered orally
• Androgen deprivation therapy (ADT)
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

Locations

Country	Name	City	State
India	Site IN00002	Ahmedabad
India	Site IN00004	Hubli
India	Site IN00008	Kolkata
India	Site IN00003	Nashik
India	Site IN00007	Nashik
India	Site IN00010	New Delhi
India	Site IN00001	Pune
India	Site IN00011	Surat

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of participants with laboratory test abnormalities and/or AEs	Number of participants with potentially clinically significant laboratory values.	Up to 10 months
Primary	Number of participants with physical examination abnormalities and/or AEs	Number of participants with potentially clinically significant physical examination values.	Up to 10 months
Primary	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	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