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NCT06072196COMPLETED

A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population

Sponsor: Pfizer + Astellas Pharma Inc

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
OBSERVATIONAL
Conditions
Prostatic Neoplasms
Interventions
Novel hormonal therapy
Enrollment
3,017 participants
Primary completion
Dec 2024
Study completion
Dec 2024
First posted
Oct 2023
Last updated
Dec 2025

Primary Endpoints (CT.gov)

Duration of NHT Treatment

Time frame: 2 years (retrospective data observation duration)

Eligibility Criteria

Inclusion Criteria: * Male with ≥ 1 diagnosis claim for prostate cancer * Have documented secondary metastasis code on or after the initial prostate cancer diagnosis * Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date. * Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date * ≥65 years old 12 months prior to the index date * Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death) Exclusion Criteria: * Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance * Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or sur

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✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov