Promising prostate cancer combo study halted early
NCT ID NCT05009290
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding the drug SHR3680 to standard hormone therapy could improve outcomes for men with high-risk prostate cancer before they had surgery to remove the prostate. The trial enrolled 391 participants and aimed to see if the combination could eliminate all cancer in the removed prostate or delay the spread of cancer. The study was terminated early, so final results are not yet available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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391 people
The number who actually took part.
- Started
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Nov 2021
- Finished
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Sep 2024
- 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. Age of ≥ 18 years old; 2. ECOG PS score of 0 or 1; 3. Pathologically diagnosed as prostate adenocarcinoma; 4. High-risk patients 5. No distant metastasis (clinical staging of M0) as determined by BICR of imaging examinations; 6. Subjects who are candidates for and plan to undergo radical prostatectomy (removal of the entire prostate and seminal vesicle plus pelvic lymphadenectomy); Exclusion Criteria: 1. Subjects who received any prior treatment for prostate cancer, except medical ADT and/or first-generation androgen receptor antagonists (such as bicalutamide) for not more than 4 weeks; 2. Subjects who received any other investigational products or underwent major surgery within 4 weeks prior to randomization; 3. Subjects who are planning bilateral orchidectomy during the treatment period of the study; 4. Subjects with dysphagia, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption; 5. Subjects with a history of epilepsy, or diseases that can induce seizures occurred within 12 months prior to randomization (including a history of transient ischemic attack, stroke, traumatic brain injury, and cognitive impairment, requiring hospitalization); 6. Subjects with active heart disease within 6 months prior to randomization, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure, and ventricular arrhythmias requiring medical treatment;
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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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Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, China