Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorHTA Co., Ltd.
About this trial
In this study, 18F-Florastamin PET/CT will be performed in patients with suspected recurrence of prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.
Eligibility criteria
Qualifiers
Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
Male ≥ 18 years of age.
Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
At least 6 weeks after radical prostatectomy (RP): PSA ≥0.2 ng/mL followed by a subsequent confirmatory PSA value ≥0.2 ng/mL.; or
Disqualifiers
Subjects who have participated in other interventional clinical trials before signing ICF and were within the 5 half-lives of the investigational drug, or who are currently participating in other interventional clinical trials or have participated in clinical trials of radioactive drugs before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.
Intravenous injection of iodinated contrast medium within 24 hours, or any high-density oral contrast medium (Such as barium sulfate. Oral water contrast is acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior to study drug administration.
Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
Trial design
Treatments tested in this trial
- Florastamin[18F] Injection
Treatment groups
131 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov