Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer

A Multicenter Study Evaluating the Efficacy and Safety of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer

The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.

Inclusion Criteria:

• 1. Histological or cytological diagnosis of prostate cancer;；
• Advanced prostate cancer patients eligible for endocrine therapy, able to receive continuous androgen deprivation therapy for at least 6 months.
• Serum testosterone ≥150 ng/dL (5.2nmol/L) at screening visit;
• The Eastern Cooperative Oncology Group (ECOG) score is 0 to 1.

Exclusion Criteria:

• Diagnosed or suspected of hormone-resistant prostate cancer;
• For prostate cancer patients who have had or are undergoing endocrine therapy
• Patients who have previously undergone pituitectomy or adrenalectomy or have pituitary disease or adrenal dysfunction;
• Those who have had any prostate surgery within 4 weeks prior to initial dosing or prostate surgery or other major surgical treatment during the planned trial period (except urinary tract obstruction relief);
• The imaging results of screening visits clearly showed the presence of brain metastases;