Clinical Trial

A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer

Unknown Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated December 12, 2023 (before its estimated July 31, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT06029036
Lead Sponsor Peking University First Hospital
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Air Force Medicial University
Conditions Prostate Cancer
Enrollment 53 participants
Start Date 2023-08-05
Primary Completion 2025-07-31 (estimated)
Study Completion 2026-07-31 (estimated)
Updated on ClinicalTrials.gov 2023-12-12