A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide

Sponsor
Janssen-Cilag Ltd.
Study ID
NCT05901649
Status
Completed

Conditions

  • Metastatic Hormone-sensitive Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Apalutamide — DRUG
    No interventions will be administered as a part of this study. Participants will receive apalutamide as per their routine clinical practice.
  • Enzalutamide — DRUG
    No interventions will be administered as a part of this study. Participants will receive enzalutamide as per their routine clinical practice.

Study Details

The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Dates

First listed
Jun 13, 2023
Start date
Jul 5, 2023
Status verified
Jul 2026
Primary completion
Jun 16, 2026
Completion
Jun 16, 2026

Study Design

Enrollment
505 participants (actual)

Arms

  • Arm: Apalutamide Plus Androgen Deprivation Therapy (ADT)
    Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
  • Arm: Enzalutamide Plus Androgen Deprivation Therapy (ADT)
    Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.

Primary Outcome Measure

Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3 [ Time Frame: At month 3 ]

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