Not yet recruiting NCT06837896
Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLG1080.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Study Evaluating the Efficacy and Safety of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
Overview
The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.
Interventions
- Drug QLG1080
Oral administration
Primary outcome measures
- Sustained castration rate of serum testosterone [Time frame: From study day 29 to the end of the study]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06837896 · QLG1080-301