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

Phase 3

Not yet recruiting

• Conditions: Prostate Cancer
• Interventions: Drug: QLG1080

• Registration Number: NCT06837896
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-20
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-11
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 110

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QLG1080	QLG1080	-

Primary Outcome Measures

Name	Time	Method
Sustained castration rate of serum testosterone	From study day 29 to the end of the study	The cumulative probability of serum testosterone levels reaching and maintaining castration levels (≤50 ng/dL or 1.7 nmol/L)