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NCT05202301
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
trial testing Darolutamide (Nubeqa, BAY1841788) in Prostate Cancer in 13,779 participants. Completed in 15 July 2025.
15 July 2025
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 13,779 |
| Start date | 15 January 2022 |
| Primary completion | 15 July 2025 |
| Estimated completion | 15 July 2025 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Darolutamide (Nubeqa, BAY1841788) — full drug profile →
- Enzalutamide (enzalutamide) — full drug profile →
- Apalutamide (apalutamide) — full drug profile →
Conditions studied
- Prostate Cancer — all drugs for Prostate Cancer →
Sponsor
Bayer — full company profile →
Who can join
18 and older, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05202301
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Darolutamide (Nubeqa, BAY1841788)
Trials testing the same drug.
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- NCT06204302 — An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetas · completed
- NCT05348876 — A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Add · Phase 4 · recruiting
- NCT05362149 — An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Me · completed
- NCT04736199 — Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer · Phase 3 · completed
Other recruiting trials for Prostate Cancer
Currently open trials in the same condition.
- NCT06960798 — Characterizing the Genomic Landscape of Prostate Cancer in Native American Populations (NAT-Geno) · recruiting
- NCT07237269 — Abi/Pred + ADT vs ADT in PSMA-Positive, Conventionally Node-Negative Prostate Cancer · Phase 2 · recruiting
- NCT07234981 — PSMA-PET Guided De-escalation of Salvage Radiation Treatment in Recurrent Prostate Cancer · Phase 2 · recruiting
- NCT07027124 — Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Ris · Phase 2 · recruiting
- NCT07426094 — PRO-BOOST-N: Prostate-First Versus Combined Prostate and Nodal Dose Escalation in PSMA PET-Staged Node-Positive Prostate · Phase 2, PHASE3 · recruiting
Other Bayer trials
Trials by the same sponsor.
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- NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
- NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
- NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
- NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05202301 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bayer
- Last refreshed: 11 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05202301.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing