Clin2
NCT05348876Possibly a fitRecruiting

Darolutamide plus standard hormone therapy for high-risk prostate cancer

Non-metastatic Castration-resistant Prostate Cancer

Treatments studied

Part of Cancer, Kidney & urinary clinical trials.

This trial studies how safe darolutamide is and how well it works when added to standard hormone therapy for men with high-risk, non-metastatic prostate cancer that is no longer responding to hormone treatment. It may help slow prostate cancer growth and reduce prostate-specific antigen (PSA) rises in real-world care.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 4
Enrollment
50 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You can sign informed consent and are a man age 18 or older.
  • You have confirmed prostate cancer that is not a rare neuroendocrine/small-cell type.
  • Your cancer has become resistant to standard hormone therapy: while on continuous ADT you’ve had at least 3 rising PSA tests over time, and your PSA at screening is at least 1.0 ng/mL.
  • Your testosterone is in the “castrate” range (a specific lab number showing hormone suppression) while on treatment or after both testicles are removed.
  • Your PSA is doubling “fast enough” to meet the trial rule (PSA doubling time of 10 months or less).
  • You can join routine trial visits and take the study pills as required, and you do not need to skip due to swallowing problems or inability to follow the schedule.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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