Actively Recruiting
Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer
Led by Sinotau Pharmaceutical Group · Updated on 2025-08-11
121
Participants Needed
1
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
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
CONDITIONS
Official Title
Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand the study and voluntarily sign the informed consent form
- Male, aged 18 years or older
- Previously treated with one or more of the following: radical prostatectomy, prostatectomy with adjuvant radiotherapy, prostatectomy with adjuvant androgen deprivation therapy, radical radiotherapy, or focal gland therapy
- Clinically suspected biochemical recurrence with PSA levels meeting one of the following: after prostatectomy, PSA ≥ 0.2 ng/mL confirmed on subsequent test; after radiotherapy or focal gland therapy, PSA increased by at least 2 ng/mL from the lowest level
- Willing to have histopathological confirmation or further imaging if positive lesions are found
- Males with reproductive potential must agree to effective contraception during the study and for 6 months after completion, as must their partners
You will not qualify if you...
- Planned to receive X-ray contrast or other radioactive imaging agents within 24 hours before PET imaging
- Participation in another interventional clinical trial with a new drug or treatment within 30 days or 5 half-lives before PET imaging
- Known allergy to Flotufolastat F-18 or its ingredients
- Claustrophobia or inability to tolerate imaging exams
- Poor compliance or judged unsuitable by the investigator
- Any condition that may interfere with data collection or study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100089
Actively Recruiting
Research Team
R
Ruimin Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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