A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Status:
Recruiting
Trial end date:
2026-07-31
Target enrollment:
Participant gender:
Summary
Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher
rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death.
Novel hormone therapies(NHT) have shown a significant survival advantage with respect to
classical ADT in later stages of PCa and have already been investigated in neoadjuvant
setting.
PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological
downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for
high-risk localized prostate cancer patients.
Phase:
Phase 2
Details
Lead Sponsor:
Peking University First Hospital
Collaborators:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Xijing Hospital of Air Force Military Medical University