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

Qilu Pharmaceutical

Status and phase

Not yet enrolling

Phase 3

Conditions

Prostate Cancer

Treatments

Drug: QLG1080

Study type

Interventional

Funder types

Industry

Identifiers

QLG1080-301

Details and patient eligibility

About

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

Enrollment

110 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;