Can chemo before surgery stop prostate cancer from spreading?
NCT ID NCT03258320
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving chemotherapy before surgery can help control high-risk prostate cancer and prevent it from coming back or spreading. About 300 men aged 40 to 75 will receive one of four chemo drugs followed by prostate removal. The goal is to see if this approach improves 5-year survival without the cancer returning.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2015
- 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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40 to 75 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: * 40 ≤ age ≤ 75 years with histologically proven PCa * no severe major organ dysfunction * WHO performance status of 0 or 1 * no prior cancer chemotherapy * A Clinical Stage ≥ T2c (T2c, N0, M0) of prostate cancer but ideally without diagnosed distant metastasis (according to the 2016 American Joint Committee on Cancer (AJCC) definition of TNM staging system, Staging Manual, Eighth Edition) as determined by a preoperative evaluation that included a pleural computed tomography (CT) scan. Exclusion Criteria: * age ≥ 76 * severe major organ dysfunction * WHO performance status of \>1 * prior cancer chemotherapy * Stage IV.
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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
2 sites. 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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Qilu Hospital of Shandong University
RECRUITINGQingdao, Shandong, 266035, China
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Zhongshan Hospital
RECRUITINGShanghai, 200032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- AI chatbot aims to demystify prostate cancer radiation — a trial puts it to the test
- Exercise may counteract side effects of prostate cancer hormone therapy
- Combination therapy aims to wipe out High-Risk prostate cancer before surgery
- Can a digital guide boost genetic testing in prostate cancer survivors?