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

Launched by QILU PHARMACEUTICAL CO., LTD. · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called QLG1080 for men with hormone-sensitive advanced prostate cancer. The goal is to see how well this treatment works and to check if it is safe for patients. The trial is currently not recruiting participants, but it is focused on men aged 65 to 74 who have been diagnosed with prostate cancer that requires hormone therapy. To qualify for the trial, participants must be able to receive continuous hormone treatment for at least six months and have certain levels of testosterone in their blood.

If eligible, participants can expect to be closely monitored throughout the trial to assess their response to the treatment and any side effects they may experience. It's important to note that men who have hormone-resistant prostate cancer or certain other medical conditions, like recent surgeries or specific hormone-related disorders, will not be able to join the study. This trial aims to provide valuable information about a potential new option for treating advanced prostate cancer.

Gender

MALE

Eligibility criteria

• 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;