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

NCT06837896 | Completed Phase 3

• 1 other identifier: QLG1080-301
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Sustained castration rate of serum testosterone

  The cumulative probability of serum testosterone levels reaching and maintaining castration levels (≤50 ng/dL or 1.7 nmol/L)

  From study day 29 to the end of the study

Study Arms (1)

QLG1080

EXPERIMENTAL

Drug: QLG1080

Interventions

QLG1080 DRUG

Oral administration

QLG1080

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

No. 8888 Lvyou Road

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: March 11, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: September 3, 2026

Record last verified: 2026-09

Locations

CN (1)