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

NCT05202301 | Completed

• 1 other identifier: 22053
• Study Type: observational
• Target: 13,779
• Locations: 1 country
• Sites: 1

Brief Summary

This is an observational study in which patient data from the past on men with prostate cancer are studied. Cancer is a condition in which the body cannot control the growth of cells and tumors may form. If tumors form in the prostate, male sex hormones (androgens) can sometimes help the cancer spread and grow. Cancer that spreads to other parts of the body is called metastasis. Androgens are mainly made in the testicles. There are treatments available for men with prostate cancer to lower the levels of these hormones in the body. These treatments are called androgen deprivation therapy (ADT). Some men with prostate cancer respond to ADT, but in some cases, prostate cancer may overcome the therapy and worsen despite low androgens levels. Second generation androgen receptor inhibitors (SGARIs) including darolutamide, apalutamide, and enzalutamide are available for the treatment of prostate cancer in addition to ADT. SGARIs work by blocking androgens from attaching to proteins in cancer cells in the prostate. Clinical studies have shown that men with prostate cancer benefit from these treatments. But besides benefits, unfavorable reactions related to these treatments also influence which treatment is chosen, if the treatment is taken as intended or if it is even stopped. Unfavorable reactions observed for darolutamide, apalutamide, and enzalutamide differ from each other. In clinical trials, severe unfavorable reactions occurred less often for darolutamide. But information on how unfavorable reactions of each treatment influence their intake in actual or "real-world" prostate cancer treatment is missing. The main aim of this observational study is to learn to what extent SGARI treatments are taken as prescribed and how often their intake is completely stopped. To find this out, researchers will collect available treatment data of adult men with prostate cancer from the United States who started SGARI treatments between August 2019 and March 2021. The data will be drawn from the IQVIA database. For each man, data from up to 1 year prior SGARI treatment until at least 3 months after treatment start (up to the 30 June 2021) will be collected. The researchers will look at the percentage of men who:

• completely stopped to take their treatment or
• took the treatment as prescribed. The results for each treatment (darolutamide, apalutamide, and enzalutamide) will then be compared to find possible differences. There will be no required visits with a study doctor or required tests in this study since only patient data from the past are studied.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• Discontinuation rate of SGARI treatment

  The proportion of patients who discontinue their index SGARI treatment at 3 months, 6 months, 1 year and acutely (discontinuation within 90 days) will be evaluated. In addition, time to discontinuation will be assessed. Discontinuation will be defined as a gap of ≥60 days from the end of the days of supply (DOS) of a prescription claim for the index SGARI to the date of the next prescription claim. The date of the last day of supply for the prescription claim that occurs immediately prior to the gap will be defined as the date of discontinuation. Discontinuation rate will be defined as the proportion of patients with discontinuation within a set time period (3 months, 6 months, 1 year).

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

• Time to discontinuation (days) of SGARI treatment

  Time to discontinuation will be assessed over the entire observation period

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

• Adherence of SGARI treatment

  Medication adherence will be assessed using medication possession ratio (MPR) and proportion of days covered (PDC)

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

Secondary Outcomes (10)

• Treatment duration of SGARI treatment

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

• Risk factors for treatment discontinuation

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

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

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

• Time to first dose modification (days) of index SGARI treatment

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

• Descriptive summary of the baseline demographics of Prostate Cancer (PC) patients treated with SGARIs

  Retrospective analysis during index identification period, from 01-Aug-2018 up to 31-Mar-2021

Study Arms (3)

Darolutamide cohort (Daro)

Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Darolutamide as initial treatment

Drug: Darolutamide (Nubeqa, BAY1841788)

Enzalutamide cohort (Enza)

Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Enzalutamide as initial treatment

Drug: Enzalutamide

Apalutamide cohort (Apa)

Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Apalutamide as initial treatment

Drug: Apalutamide

Interventions

Darolutamide (Nubeqa, BAY1841788) DRUG

Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database

Darolutamide cohort (Daro)

Enzalutamide DRUG

Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database

Enzalutamide cohort (Enza)

Apalutamide DRUG

Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database

Apalutamide cohort (Apa)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with Prostate Cancer who newly initiate Second Generation Androgen Receptor Inhibitors treatment in United States from 01 Aug 2019 to 31 Mar 2021.

You may qualify if:

• 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.

You may not qualify if:

• Since patients should not be prescribed more than one SGARI when initiating treatment, patients with more than one SGARI prescribed on the index date will be excluded from the study. This will allow each patient to be assigned to a single study cohort.
• In order to select patients who are initiating SGARI treatment, patients with the index SGARI treatment during the 1 year baseline period will be excluded from the study.

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

Related Links

• Click here for access to information about Bayer's transparency standards and Bayer studies

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide; enzalutamide; apalutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 21, 2022
• Study Start: January 15, 2022
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)