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

Part of paid clinical trials in Whippany, New Jersey.

Sponsor
Bayer
Study ID
NCT05202301
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Darolutamide (Nubeqa, BAY1841788) — DRUG
    Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database
  • Enzalutamide — DRUG
    Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database
  • Apalutamide — DRUG
    Retrospective cohort analysis, using the IQVIA Real-World Data Adjudicated Claims, US claims database

Study Details

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.

Key Dates

Start date
Jan 15, 2022
Status verified
Aug 2025
Primary completion
Jul 15, 2025
Completion
Jul 15, 2025

Study Design

Enrollment
13,779 participants (actual)

Arms

  • Arm: Darolutamide cohort (Daro)
    Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Darolutamide as initial treatment
  • Arm: Enzalutamide cohort (Enza)
    Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Enzalutamide as initial treatment
  • Arm: Apalutamide cohort (Apa)
    Participants received Second Generation Androgen Receptor Inhibitor (SGARI) Apalutamide as initial treatment

Primary Outcome Measure

Discontinuation rate of SGARI treatment [ Time Frame: Retrospective analysis from index date 01-Aug-2019 up to 30-Jun-2021 ]

Locations (1)

FacilityCityStateZIPSite coordinators
BayerWhippanyNew Jersey07981-

Find similar trials in Whippany, NJ

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Bayer· Whippany, NJ

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