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NCT07086651COMPLETED

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

Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database

Sponsor: Pfizer + Astellas Pharma Inc

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Key Facts

Study type
OBSERVATIONAL
Conditions
Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms, Prostate Cancer
Interventions
Enzalutamide, Apalutamide
Enrollment
1,300 participants
Primary completion
Oct 2025
Study completion
Oct 2025
First posted
Jul 2025
Last updated
Dec 2025

Primary Endpoints (CT.gov)

Treatment duration

Time frame: Up to approximately 65 months

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

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov