Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer
Recruiting · NCT07115277 · Interventional (participants receive a specific treatment) · Lead sponsor: Sinotau Pharmaceutical Group
View the official record on ClinicalTrials.gov →Interventions studied
Flotufolastat F-18 Injection
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- \. 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.
Exclusion criteria
- 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
1 location listed.
- Chinese PLA General Hospital - Beijing, Beijing Municipality, China