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NCT06435702

Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Sponsor: Peking University Third Hospital

View on ClinicalTrials.gov

Summary

This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.

Official title: A Prospective Observational Cohort Study of Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy

Key Details

Gender

MALE

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

108

Start Date

2024-06-01

Completion Date

2029-12-31

Last Updated

2024-05-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Darolutamide in addition to androgen deprivation therapy

Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration

DRUG

androgen deprivation therapy only

The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.

Locations (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China