Clinical trial · Interventional
Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
A Multicenter Study Evaluating the Efficacy and Safety of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
NCT06837896CI-TRIAL-00125764completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study was to evaluate the efficacy and safety of QLG1080 in patients with hormone-sensitive advanced prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLG1080 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLG1080
- interventionNames
- Drug: QLG1080
Primary outcomes (1)
- measure
- Sustained castration rate of serum testosterone
- timeFrame
- From study day 29 to the end of the study
- description
- The cumulative probability of serum testosterone levels reaching and maintaining castration levels (≤50 ng/dL or 1.7 nmol/L)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available
No reference posted for this study.