NCT07115277 Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer

Trial Parameters

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Brief Summary

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

Eligibility Criteria

Inclusion Criteria: 1\. 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: 1. Radical prostatectomy (RP); 2. RP with adjuvant radiotherapy (RT); 3. RP with adjuvant androgen deprivation therapy (ADT); 4. Radical RT or focal gland therapy (e.g., brachytherapy, high-intensity focused ultrasound \[HIFU\]). 4\. Clinically suspected BCR, serum PSA levels should meet at least one of the followings: 1. After RP with or without adjuvant or salvage therapy: PSA≥ 0.2 ng/mL, and subsequent confirmation that PSA ≥ 0.2 ng/mL. 2. After RT as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir. 3. After focal gland therapy as primary treatment: PSA increased at least 2 ng/mL compaire to the nadir. 5\. 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

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