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NCT05202301COMPLETED

A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely

Medication Adherence and Discontinuation Among Patients With Prostate Cancer Who Initiated Second Generation Androgen Receptor Inhibitors

Sponsor: Bayer

No open prediction endpoints

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Key Facts

Study type
OBSERVATIONAL
Conditions
Prostate Cancer
Interventions
Darolutamide (Nubeqa, BAY1841788), Enzalutamide, Apalutamide
Enrollment
13,779 participants
Primary completion
Jul 2025
Study completion
Jul 2025
First posted
Jan 2022
Last updated
Aug 2025

Primary Endpoints (CT.gov)

Discontinuation rate of SGARI treatment

Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021

Time to discontinuation (days) of SGARI treatment

Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021

Adherence of SGARI treatment

Time frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021

Secondary Endpoints

Treatment duration of SGARI treatment

Risk factors for treatment discontinuation

The proportion of patients who had evidence of dose modification of their index SGARI treatment

Eligibility Criteria

Inclusion Criteria: * Have at least 1 prescription claims for enzalutamide (National Drug Code \[NDC\]: 00469-0125-99, 00469-0625-99, 00469-0725-60), apalutamide (NDC: 59676-600-12, 59676-600-56, 59676-600-99) or darolutamide (NDC: 50419-395-01, 50419-395-72) during the index identification period. \-- The date of the earliest SGARI claim to occur during this period will be defined as the index date with the corresponding SGARI as the index treatment. * Have ≥1 diagnosis of prostate cancer (ICD-10 code C61.) during the overall baseline period. * Age ≥18 years and male gender on the index date. * Have continuous health plan enrollment with medical and pharmacy benefits for at least 6 months prior to the index date. * Have continuous health plan enrollment with medical and pharmacy benefits for at least 3 months after the index date and throughout the follow-up period. Exclusion Criteria: * Since patients should not be prescribed more than one SGARI when initiating treatment, patie

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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