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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

NCT06435702 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2024-05-30

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Peking University Third Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2026-07-01
Completion
2029-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06435702 on ClinicalTrials.gov