Can a pill replace injections to fight advanced prostate cancer?
NCT ID NCT06837896
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This Phase 3 trial tests an oral drug called QLG1080 in men with hormone-sensitive advanced prostate cancer. The goal is to see if the drug can safely lower testosterone to castration levels, which helps slow cancer growth. Participants must be eligible for endocrine therapy and able to continue androgen deprivation for at least six months. The study measures how many men maintain castration-level testosterone over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- QLG1080, an oral drug being tested to lower testosterone to castration levels in men with advanced prostate cancer
- What this could lead to
- If QLG1080 works, it could offer a new oral option to suppress testosterone and help control advanced prostate cancer without injections.
- What could go wrong
- This is an early-stage test in a small group of 111 men. The drug may not maintain castration levels in all patients, and side effects are still being evaluated.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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111 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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No. 8888 Lvyou Road
Jinan, Shandong, 250000, China
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