drugset / Trial / NCT06029036
A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer
Phase 2
Recruiting
53 enrolled
Peking University First Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · collabThe First Affiliated Hospital of Air Force Medicial University · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-08-05
- Primary completion
- 2025-07-31
- Completion
- 2026-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darolutamide | Other / unclassified | 600 mg | Oral |