Clinical Trial

Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical Study

Not Yet Recruiting Early Phase 1
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Summary
Previous study findings suggest that the efficacy limitations of the neoadjuvant treatment regimen combining docetaxel with androgen deprivation therapy are associated with protein synthesis. Homoharringtonine (HHT) is currently the only small-molecule translation elongation inhibitor approved by the U.S. Food and Drug Administration (FDA). Building on this foundation, we plan to conduct a prospective interventional study aimed at validating whether the intensified quadruple regimen, formed by adding darolutamide and homoharringtonine (HHT) to the standard regimen, can further significantly enhance the depth of pathological response and improve patient outcomes through multi-mechanism synergy.
Trial Details
NCT Number NCT07516704
Lead Sponsor Zhongda Hospital
Conditions Prostate Cancer
Enrollment 94 participants
Start Date 2026-04-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2027-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-04-08