NCT06837896

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at below P25 for phase_3 prostate-cancer

Timeline
6mo left

Started Feb 2025

Shorter than P25 for phase_3 prostate-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress71%
Feb 2025Dec 2026

Study Start

First participant enrolled

February 1, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 20, 2025

Status Verified

February 1, 2025

Enrollment Period

1.7 years

First QC Date

February 17, 2025

Last Update Submit

February 17, 2025

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

QLG1080DRUG

Oral administration

QLG1080

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Central Study Contacts

Nianzeng Xing, Doctor of Medicine

CONTACT

8610-87788495cancergcp@163.com

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

February 1, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 20, 2025

Record last verified: 2025-02