A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)

Launched by PFIZER · Jul 18, 2025

Keywords

ClinConnect Summary

This study is looking at how long men with a type of prostate cancer called metastatic castration-sensitive prostate cancer (mCSPC) take two medicines, apalutamide and enzalutamide, as part of their treatment. Prostate cancer is a common cancer in men, and metastatic means the cancer has spread to other parts of the body. Castration-sensitive means the cancer is still responding to treatments that lower testosterone, a hormone that can help the cancer grow. Instead of testing new treatments, this study will use information from real patients receiving care in cancer clinics to see how long these medicines are used in everyday healthcare.

Men who might be part of this study are those diagnosed with mCSPC who started treatment with either apalutamide or enzalutamide on or after January 1, 2020, and who are 18 years or older. To be included, they must have also been receiving hormone therapy to lower testosterone around the time they started these medicines. The study will look back at patient records to understand how long men stay on these treatments. Since this is a real-world study using existing medical records, participants won’t need to change their usual care or visit the clinic for extra tests. This research helps doctors learn more about how these treatments work outside of clinical trials and in everyday practice.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Male patients diagnosed with metastatic prostate cancer
• • Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
• • Index date on or after 1 January 2020
• • Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
• • Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died
• Exclusion Criteria:
• • Evidence of castration-resistance prior to the index date
• • Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
• • Evidence of ADT use between 1 year and 91 days prior to the index date
• • Had a prior history of other cancers