New PET tracer for prostate cancer enters human testing
NCT ID NCT07149831
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-stage trial is testing a new imaging agent called Flotufolastat F-18 in 6 healthy Chinese adults. The tracer is designed to light up prostate cancer cells during PET scans. Researchers are checking how safe it is, where it goes in the body, and how much radiation it gives off. This is a first step before testing it in people with prostate cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flotufolastat F-18 Injection
- What this could lead to
- If successful, this could lead to a more accurate PET imaging method for detecting prostate cancer, potentially improving diagnosis and treatment planning.
- What could go wrong
- This is a very early Phase I trial with only 6 healthy volunteers, not patients. It only tests safety and imaging properties, not whether it actually helps diagnose cancer better than existing methods.
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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Dec 2025
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 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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. Have the ability to understand the content of study and voluntarily sign the informed consent form. 2. Healthy male or female, aged 18-60 (included). 3. Body mass index (BMI) between 19 and 26 kg/m² (included). 4. Vital signs, physical examination, 12-lead electrocardiogram (ECG), chest X-ray (posterior-anterior view), and abdominal ultrasound are normal, or any abnormalities that are diagnosed clinically insignificant. 5. Clinical laboratory test results are within normal ranges or any abnormalities that are diagnosed clinically insignificant. 6. Have the ability to communicate effectively with the investigator and comply with the study requirement to follow-up. 7. Female subject shouldcontracept effectively during the study period and 6 months after the study completed (effective contraception includes sterilization, intrauterine hormonal devices, condoms, contraceptive pills/agents, abstinence, or partner vasectomy). Male subject should agree to use contraception during the study period and 6 months after the study completed. Exclusion Criteria: 1. Claustrophobia or inability to tolerate imaging examinations for any other reason. 2. Have a history of epilepsy or seizures, excluding childhood febrile seizures. 3. With chronic diseases, including but not limited to: 1. cardiovascular, respiratory, gastrointestinal, urinary, hematological disease, neurological, endocrine, metabolic, or musculoskeletal diseases, or a history thereof. 2. history of psychiatric disorders or currently significant psychiatric conditions 4. Have a history of asthma or allergies. 5. Have a history of malignant tumors. 6. Present any condition that may interfere with the absorption or metabolism of the investigational drug, or that may affect study results, as determined by the investigator to be clinically significant. 7. Underwent any surgical procedure within 3 months before administration or planned surgery during the study period. 8. Accomplished the blood donation or significant blood loss (\>400 mL) within 3 months before administration or during the screening period. 9. Insufficient venous access (two distinct venous lines are required for investigational drug administration and PK sampling). 10. Known allergy to the active ingredient or any excipients of the investigational product. 11. Took any medications, including prescription, over-the-counter drugs, or herbal remedies, within 14 days before administration. 12. Participated any other new drug's clinical trial within 4 weeks prior to the administration or within 5 half-lives of the investigating drug (whichever is longer). 13. Radiopharmaceutical imaging or treatment within 7 days prior to screening or within 5 half-lives of the radiopharmaceutical (whichever is longer). 14. Pregnant or breastfeeding women. 15. Abnormal serological results (hepatitis B surface antigen, syphilis treponemal antibody, human immunodeficiency virus antibody, hepatitis C antibody) diagnosed clinically significant by the investigator. 16. QTc intervalis longer than 450 milliseconds during the screening period. 17. Major occupational exposure to ionizing radiation in the past 10 years (e.g., more than 50 mSv/year) or exposure to radioactive materials or ionizing radiation for therapeutic or research purposes. 18. Any reason determined by the investigator that could not complet the study.
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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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Chinese PLA General Hospital
RECRUITINGBeijing, Beijing Municipality, 100089, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- 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?
- A scanner in the operating room could show surgeons exactly where prostate cancer remains