Prostate Cancer
Conditions
Brief summary
The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.
Interventions
DRUGQLG1080
Oral administration
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
China
Outcome results
None listed