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NCT Number: NCT06837896

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

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

QLG1080

Drug

Oral administration

Primary outcomes

  1. Sustained castration rate of serum testosterone

    Time frame: From study day 29 to the end of the study

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

Study contacts

Contact information is provided by the study sponsor or research team.

Nianzeng Xing, Doctor of Medicine

CONTACT

[email protected]

8610-87788495

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multicenter Study Evaluating the Efficacy and Safety of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2025
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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