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

Status and phase: Completed; Phase 4

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Drug: Enzalutamide; Drug: Androgen deprivation therapy (ADT)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03641560

9785-CL-0413

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Enzalutamide

Experimental group

Description:

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.

Treatment:

Drug: Androgen deprivation therapy (ADT)

Drug: Enzalutamide