drugset / Trial / NCT06575257

Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

NCT06575257

Phase 2 Recruiting 80 enrolled Xijing Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.

Timeline

Start
2024-05-01
Primary completion
2026-05
Completion
2029-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Darolutamide Other / unclassified 600 mg Oral
Background Goserelin Other / unclassified 3.6 mg Other

Indications