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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

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

Study ID: NCT06435702

Conditions

Prostate Cancer

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Peking University Third Hospital, Beijing, Beijing, China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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