NCT06575257

Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Darolutamide	600 mg orally twice daily for 12 weeks before radical prostatectomy
DRUG	Goserelin 3.6 mg	3.6 mg goserelin hypodermic once per 4 weeks

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-05-01
• Completion: 2029-05-01
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

1 site across 1 country: China