An Observational Study Conducted in China to Evaluate the Efficacy and Safety of Darolutamide in Combination With Androgen Deprivation Therapy (ADT) for Men With Non-metastatic Prostate Cancer That Progressed Following Prior Bicalutamide + ADT Treatment
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
In this observational study, participants receive darolutamide: a treatment that is already available for doctors to prescribe for non-metastatic castration-resistant prostate cancer (nmCRPC) or metastatic hormone-sensitive prostate cancer (mHSPC). Prostate cancer is a common cancer in men, and the number of cases is rising, especially in China. Many men are diagnosed at a late stage, which makes treatment more difficult. Standard treatment for prostate cancer often includes lowering the levels of male hormones (androgens) in the body, as these hormones can help the cancer grow. This is called androgen deprivation therapy (ADT). Sometimes, medicines like bicalutamide are added to ADT, but over time, the cancer can become resistant to these treatments. When this happens and the cancer has not yet spread to other parts of the body, it is called nmCRPC. Newer agents, such as darolutamide, have demonstrated efficacy in controlling the disease and delaying progression, with a more favorable safety profile and fewer severe adverse events than conventional therapies. This study wants to observe how effective darolutamide plus ADT is at controlling the cancer in Chinese men with nmCRPC who have already been treated with bicalutamide plus ADT during an earlier stage of their disease, known as non-metastatic hormone-sensitive prostate cancer (nmHSPC), but whose cancer has since progressed despite that treatment. The study will look at how many participants have their prostate-specific antigen (PSA) levels drop to undetectable levels within 6 months of starting darolutamide (in the main group of 800 participants). PSA is a protein made by the prostate, and high levels can be a sign of prostate cancer. In a smaller group of 100 participants, the study will also look at how many men remain free from PSA progression (a sign that the cancer is not getting worse) after 12 months. To learn more about the safety of darolutamide, the researchers will study whether the participants have adverse events. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. The researchers will also learn more about how well darolutamide is working in these participants.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyzna w wieku co najmniej 18 lat
- •Stan zdrowia na tyle dobry, aby tolerować leczenie (wyniku ECOG 0 lub 1)
- •Otrzymanie leczenia hormonalnego z bicalutamidem przez co najmniej 6 miesięcy, a następnie progresja raka
- •Bardzo niskie poziomy testosteronu we krwi (poniżej 1,7 nmol/L)
- •Brak przerzutów potwierdzony badaniami obrazowymi (tomografia komputerowa lub rezonans magnetyczny)
- •Podpisana świadoma zgoda na uczestnictwo w badaniu
- •Mężczyźni zdolni do reprodukcji muszą używać antykoncepcji i nie oddawać nasienia przez badanie i 3 miesiące po jego zakończeniu
✗ Disqualifies
- •Udział w innym badaniu klinicznym z innowacyjnymi lekami
- •Przerzuty do odległych narządów, w tym mózgu
- •Objawy wymagające natychmiastowej interwencji medycznej (poważne zaburzenia funkcji moczenia)
- •Wcześniejsze leczenie innymi nowoczesnymi lekami hormonalnymi (inhibitorami AR)
- •Wcześniejsze leczenie inhibitorami CYP17
- •Wcześniejsze leczenie radioaktywne, immunoterapią lub innymi badawczymi lekami
- •Poważne problemy serca (zawał, niestabilna angina, zaburzenia rytmu serca, skrzepy krwi)
- •Choroby przewodu pokarmowego wpływające na wchłanianie leków
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- August 18, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Many locations
Multiple Locations, China
Trial contact
Bayer Clinical Trials Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 8/19/2026.
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