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RECRUITING
NCT06575257
PHASE2

Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

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

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

Locations (1)

The First Affillated Hospital, the Air Force Medical University

Xi’an, Shanxi, China