---
title: Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer
nct_id: NCT06837896
overall_status: NOT_YET_RECRUITING
phase: PHASE3
sponsor: Qilu Pharmaceutical Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Prostate Cancer
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06837896.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06837896"
ct_last_update_post_date: 2025-02-20
last_seen_at: "2026-05-12T07:00:12.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety Study of QLG1080 in Patients With Hormone-sensitive Advanced Prostate Cancer

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

**NCT ID:** [NCT06837896](https://clinicaltrials.gov/study/NCT06837896)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 110
- **Lead Sponsor:** Qilu Pharmaceutical Co., Ltd.
- **Conditions:** Prostate Cancer
- **Start Date:** 2025-02
- **Completion Date:** 2026-12
- **CT.gov Last Update:** 2025-02-20

## Brief Summary

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

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
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;
```

## Arms

- **QLG1080** (EXPERIMENTAL)

## Interventions

- **QLG1080** (DRUG) — Oral administration

## Primary Outcomes

- **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)

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06837896.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06837896*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*