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

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 108 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer, using time to achieve CRPC as the primary study endpoint. OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint. It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer. It is divided into a screening period, a treatment period and a follow-up period. Patients will enter the screening period from the time they sign the informed consent form, and those who have been evaluated and qualified in the screening period will be entered into the study. Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment + darotarotide adjuvant therapy with or without combination radiotherapy at the investigator's discretion.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-07-01
• Completion: 2029-12-31
• First posted: 2024-05-30
• Last updated: 2024-05-30

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study