drugset / Trial / NCT06575257
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 600 mg | Oral |
| Background | Goserelin | Other / unclassified | 3.6 mg | Other |