Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer

Recruiting now · Not applicable

Conditions studied: Prostate Cancer

In brief

The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is: • What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard? Participants will: * Receive Flotufolastat F-18 injection * Undergo PET/CT scanning

Key facts

Study ID

NCT07115277

Run by

Sinotau Pharmaceutical Group

People needed

121

Starts

2025-03-14

Expected to finish

2026-12-31

Last updated by the study team

2025-08-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Fully understand the study and voluntarily sign the informed consent form. 2. Male, aged ≥18 years. 3. Has previously received one or more of the following treatments:
• Radical prostatectomy (RP);
• RP with adjuvant radiotherapy (RT);
• RP with adjuvant androgen deprivation therapy (ADT);
• Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound [HIFU]).
• Clinically suspected BCR, serum PSA levels should meet at least one of the followings:
• After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL.
• After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
• After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir.
• If positive lesions are detected on the XTR020 PET imaging or conventional imaging, the subject is willing to receive histopathological confirmation or the sequqnce of conventional imaging confirmation.
• Male subjects with reproductive potential must use effective contraception during the study period and 6 months after the study completed; their partners should agree to use contraception during the study period and 6 months after the study completed , too.

You may not qualify if…

• Planned to receive an X-ray contrast agent or other radioactive imaging agent within 24 hours before XTR020 PET imaging.
• Participation in an interventional clinical trial involving a new drug or treatment within 30 days or 5 biological half-lives of the drug prior to XTR020 PET imaging (whichever is longer).
• Known allergy to the active ingredient or any excipient of XTR020.
• Claustrophobia or inability to tolerate imaging examinations for any other reason.
• Poor compliance or deemed unsuitable for participation in this study by the investigator.
• Any condition that, in the opinion of the investigator, may interfere with data collection or prevent the study requirements.

Where it is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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