A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Recruiting Phase 4 Interventional Study
Non-metastatic Castration-resistant Prostate Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Bayer · Industry
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About This Trial
Researchers are looking for a better way to treat men who have non-metastatic castration-resistant prostate cancer (nmCRPC). This is a type of cancer of the prostate that has not yet spread to other parts of the body and that keeps progressing even when the amount of male sex hormones like testosterone (also called androgens) is reduced to very low levels. To reduce androgen levels in prostate can…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Capable of giving signed informed consent. * Participant must be male aged ≥ 18 years. * Histologically or cytologically confirmed adenocarcinoma of prostate without neuroendocrine differentiation or small cell features. * Castration resistance, demonstrated by: * a minimum…
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