Last reviewed · How we verify
NCT06204302: ARENA
An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States
trial testing Darolutamide (Nubeqa, BAY1841788) in Non-metastatic Prostate Cancer in 1,800 participants. Completed in 4 April 2024.
4 April 2024
Quick facts
| Lead sponsor | Bayer |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,800 |
| Start date | 5 January 2024 |
| Primary completion | 4 April 2024 |
| Estimated completion | 4 April 2024 |
| 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
- Non-metastatic Prostate Cancer — all drugs for Non-metastatic Prostate Cancer →
- Non-metastatic Castration-resistant Prostate Cancer — all drugs for Non-metastatic Castration-resistant Prostate Cancer →
Sponsor
Bayer — full company profile →
Who can join
18 and older, male only, with Non-metastatic Prostate Cancer or Non-metastatic Castration-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an observational study in which data will be collected and studied from men with non-metastatic prostate cancer (nmPC) who received their usual treatment with 'androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. Prostate cancer is a common cancer in men that starts in the prostate gland, a male reproductive gland found below the bladder. Non-metastatic means that cancer has not yet spread to other parts of the body. Darolutamide, enzalutamide, and apalutamide are already approved ARIs for nmPC in the United States (US). They work by blocking androgens (male sex hormones including testosterone) from attaching to proteins in cancer cells in the prostate. This helps to slow down the growth of the cancer cells. The participants will receive their treatments as prescribed by their doctors during routine medical care according to the approved product information. Researchers want to know more about the use of ARIs and how they affect men with nmPC in the real world. Researchers will only include men who have not been treated with any new type of medication that blocks the action of male sex hormones. The main purpose of this study is to collect and study information from men with nmPC about: * the length of time they continued treatment with an ARI as prescribed by their doctors. * the length of time from the start of the treatment with an ARI until the cancer spreads to other parts of the body. Data will come from the participants' information stored in a database called Komodo Research Dataset (KRD) in the US. The data collected will be from May 2019 to June 2023. Researchers will only track data of eligible US men with nmPC and will follow them for a minimum of 6 months or until the end of the study.
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 NCT06204302
- 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.
- NCT06334120 — An Observational Study to Learn More About the Safety of Darolutamide in Men With Prostate Cancer in Korea · recruiting
- 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
- NCT05202301 — A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androg · completed
- NCT04736199 — Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer · Phase 3 · completed
Other recruiting trials for Non-metastatic Prostate Cancer
Currently open trials in the same condition.
- NCT05617885 — Neo-DAB: Darolutamide and Abemaciclib in Prostate Cancer · Phase 1 · active not recruiting
Other Bayer trials
Trials by the same sponsor.
- NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
- 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 NCT06204302 (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: 9 April 2024
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/NCT06204302.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing