New radioactive drug targets Hard-to-Treat prostate cancer
NCT ID NCT07542379
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This early-stage trial tests a new radioactive drug called 177Lu-FC516 in 13 men with advanced prostate cancer that has stopped responding to standard treatments. The drug is given every 6 weeks for up to 4 cycles. The main goals are to find the safest dose and check for side effects, while also looking at whether the drug can shrink tumors or slow the cancer's growth.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 13 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- 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. Aged \>=18 years old. 2. Patients with metastatic castration-resistant prostate cancer who have failed standard treatments. 3. According to RECIST 1.1, there is at least one measurable lesion. 4. ECOG performance status 0-1. 5. Laboratory examination should meet: ① Blood routine: hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×10\^9/L, platelet count ( PLT) ≥100×10\^9/L; ②Blood biochemistry: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN, serum creatinine ( Cr)≤1.5×ULN or calculate the creatinine clearance ≥50 mL/min according to the Cockcroft-Gault formula method. Exclusion Criteria: 1. Received anti-tumor therapy within 4 weeks before enrollment. 2. Participated in other clinical trials within 4 weeks before enrollment and used clinical investigational drugs during this period. 3. Have undergone surgery within 4 weeks before enrollment. 4. Not recovered from the adverse reactions caused by previous anti-tumor treatments (≥CTCAE grade 1). 5. Central nervous system metastases with clinical symptoms. 6. With any situations that the researcher considers inappropriate to participate in this research.
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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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Affiliated Hospital of Jiangnan University
RECRUITINGWuxi, Jiangsu, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Training a Patient's own immune cells to fight advanced prostate cancer
- Radioactive missile aims at prostate cancer that spread
- New PET tracer targets ACP3 to spot prostate cancer
- Can a One-Week radiation course match four weeks for prostate cancer?
- Can a new PET tracer spot hidden prostate cancer spread?
- Can a gel cushion shield the rectum during prostate radiation?