Could surgery after hormone therapy beat advanced prostate cancer?
NCT ID NCT07268794
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at men with advanced prostate cancer that has spread to other parts of the body. After 6 months of hormone therapy, those whose scans show the cancer is well-controlled may either continue hormone therapy alone or also have their prostate removed. The goal is to see if adding surgery helps keep the cancer from growing back longer. About 112 men will take part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 70 years
- 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. Male patients aged \>18 and ≤70 years, or with an estimated life expectancy \>10 years. 2. Histologically or cytologically confirmed prostate adenocarcinoma with neuroendocrine differentiation ≤10%, and no small cell or signet-ring cell carcinoma component. 3. High-volume metastatic disease according to CHAARTED definition: presence of visceral metastasis and/or ≥4 bone lesions with at least one lesion outside the axial skeleton (vertebral bodies and pelvis). 4. Newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) who started intensified endocrine therapy within 3 months. 5. ECOG performance status 0-2. 6. Adequate bone marrow, liver, renal, and coagulation function as defined in the protocol (ANC ≥1.5×10\^9/L, hemoglobin ≥9.0 g/dL, platelets ≥80×10\^9/L; TBIL ≤1.5×ULN; AST/ALT/ALP ≤2.5×ULN; albumin ≥30 g/L; creatinine ≤2×ULN or creatinine clearance ≥30 mL/min; INR ≤1.5 in patients not receiving anticoagulation). 7. Patients voluntarily sign informed consent and are willing and able to comply with study procedures. Exclusion Criteria: 1. History of hypersensitivity or intolerance to any study drugs. 2. mCRPC (metastatic castration-resistant prostate cancer). 3. Oligometastatic mHSPC intended for upfront radical prostatectomy. 4. History of seizure, medications that may lower seizure threshold, or conditions predisposing to seizures (e.g., TIA, stroke, significant head trauma with loss of consciousness requiring hospitalization) within 12 months before starting study treatment. 5. Major surgery within 4 weeks prior to starting study treatment. 6. Significant cardiovascular or cerebrovascular disease within 6 months (e.g., unstable angina, myocardial infarction, NYHA class III or higher heart failure, stroke, clinically significant arrhythmia requiring treatment). 7. Conditions affecting drug intake or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction). 8. Active infection (e.g., HIV positive, HBsAg positive, HCV positive) which in the investigator's opinion may affect safety or efficacy assessment. 9. Other malignancies within the past 3 years, except adequately treated basal cell carcinoma of the skin. 10. Known brain metastases or leptomeningeal disease. 11. Concurrent participation in another interventional clinical trial or receiving other investigational drugs/devices. 12. Poor compliance or inability to adhere to study procedures and follow-up. 13. Any other severe uncontrolled comorbidities (e.g., poorly controlled hypertension, severe diabetes, neurologic or psychiatric disorders) or conditions that may interfere with study conduct or interpretation, as judged by the investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, 200032, China
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Other studies related to the condition(s) this trial covers.
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