Observational Darolutamide ADT Study for Non-metastatic Prostate Cancer, China
Summary
NIH registered an observational study (NCT07538843) on ClinicalTrials.gov evaluating darolutamide combined with androgen deprivation therapy (ADT) in Chinese men with non-metastatic castration-resistant prostate cancer (nmCRPC) whose disease progressed following prior bicalutamide plus ADT treatment. The single-arm study aims to observe treatment efficacy and safety in approximately 75 participants over 36 months using standard-of-care darolutamide.
What changed
This ClinicalTrials.gov registration describes an observational single-arm study conducted at multiple sites in China evaluating darolutamide (an androgen receptor inhibitor) in combination with ADT for men with nmCRPC following disease progression on bicalutamide plus ADT. The study will enroll approximately 75 participants and follow them for 36 months, assessing prostate-specific antigen (PSA) response rates and adverse events.
For compliance readers, this registration does not impose any regulatory obligations. It is an informational record of ongoing research in China for a drug already approved in other markets. Pharmaceutical sponsors or clinical research organizations conducting similar prostate cancer studies in China may wish to note the competitive landscape for nmCRPC trials in that region.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Observational NCT07538843 Kind: OBSERVATIONAL Apr 20, 2026
Abstract
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-spe...
Conditions: Non-metastatic Castration-resistant Prostate Cancer
Interventions: Darolutamide, ADT
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