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Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Sponsor: Xijing Hospital
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.
Official title: Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
Key Details
Gender
MALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-05-01
Completion Date
2029-05
Last Updated
2024-08-28
Healthy Volunteers
No
Conditions
Interventions
Darolutamide
600 mg orally twice daily for 12 weeks before radical prostatectomy
Goserelin 3.6 mg
3.6 mg goserelin hypodermic once per 4 weeks
Locations (1)
The First Affillated Hospital, the Air Force Medical University
Xi’an, Shanxi, China