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

NCT ID: NCT06837896

Last Updated: 2025-02-20

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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QLG1080

Group Type EXPERIMENTAL

QLG1080

Intervention Type DRUG

Oral administration

Interventions

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QLG1080

Oral administration

Intervention Type DRUG

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Nianzeng Xing, Doctor of Medicine

Role: CONTACT

8610-87788495

Other Identifiers

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QLG1080-301

Identifier Type: -

Identifier Source: org_study_id

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