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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 · View on ClinicalTrials.gov ↗
Study 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
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Enzalutamide
- DRUG Darolutamide (Nubeqa, BAY1841788)
Study Locations (1)
New Jersey
- Bayer — Whippany
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13,779 participants |
| Start Date | 2022-01-15 |
| Est. Completion | 2025-07-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05202301
The ClinicalTrials.gov registry entry for NCT05202301 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 13,779 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which Apalutamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05202301 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05202301 about?
NCT05202301 is a clinical study titled "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". 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 spr...
What is the current status of trial NCT05202301?
This trial is currently completed. The enrollment target is 13,779 participants. The study started on 2022-01-15. Estimated completion is 2025-07-15.
What conditions does trial NCT05202301 study?
This clinical trial studies the following conditions: Prostate Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05202301?
The interventions under investigation include: Apalutamide (DRUG), Enzalutamide (DRUG), Darolutamide (Nubeqa, BAY1841788) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05202301?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05202301 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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