Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
NCT ID: NCT06837896
Last Updated: 2025-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
110 participants
INTERVENTIONAL
2025-02-28
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QLG1080
QLG1080
Oral administration
Interventions
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QLG1080
Oral administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
18 Years
MALE
No
Sponsors
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Qilu Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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QLG1080-301
Identifier Type: -
Identifier Source: org_study_id
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