Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

Launched by HTA CO., LTD. · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging test called 18F-Florastamin PET/CT to see how well it can help doctors diagnose prostate cancer in men who are at least at an intermediate risk of the disease. The trial aims to check both how effective and safe this imaging method is for patients who may need surgery for their prostate cancer. To be eligible, participants must be men aged 18 or older with a confirmed diagnosis of prostate cancer and plan for surgery, but without any serious health issues that would prevent them from participating.

If you join this trial, you will undergo the 18F-Florastamin PET/CT imaging procedure, and researchers will monitor your health throughout the study. It's important to know that you will need to provide informed consent, meaning you fully understand what the study involves and any potential risks. Additionally, participants and their partners will need to use effective contraception during the study and for three months afterward. This trial is a great opportunity to contribute to research that could improve prostate cancer diagnosis and treatment for future patients.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
• • 2. Male subjects aged 18 or older.
• • 3. Subjects with histopathological diagnosis of prostate adenocarcinoma.
• • 4. According to clinical judgment, radical prostatectomy and pelvic lymph node dissection (which can include patients with localized, regional lymph node metastasis or oligometastatic prostate cancer) are planned, and there is no surgical contraindication.
• 5. If it is localized prostate cancer, according to the Prostate Cancer Diagnosis and Treatment Guidelines of 2021 Chinese Society of Clinical Oncology, it is necessary to meet any of the following criteria:
• • Intermediate Risk: Has at least one intermediate risk factor: T2b-T2c; Gleason pattern 2 or 3; PSA 10-20 ng/mL, and does not include feature of high-risk or very-high-risk groups.
• • High Risk: Has no very-high-risk features and has at least one high-risk feature: T3a; Gleason Grade Group 4 or 5; PSA \>20 ng/mL.
• • Very High Risk: Has at least one of the following: T3b-T4; Primary Gleason pattern 5; More than 4 punctures with Gleason Grade Group 4 or 5.
• • 6. ECOG score 0 or 1.
• 7. Subjects who meet the following conditions in hematology, renal function, and liver function:
• • Platelet count\>100 \* 10\^9/L
• • Urea nitrogen and creatinine\<1.5 times upper limits of normal
• • AST and ALT\<2.5 times upper limits of normal.
• • 8. Expected survival time ≥ 6 months.
• • 9. Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.
• Exclusion Criteria:
• • 1. 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 within 1 year before signing ICF and have been discontinued for less than 3 months until the signing date of ICF.
• • 2. 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.
• • 3. Subjects administered any high energy (\>300 KeV) gamma-emitting radioisotope within five physical half-lives prior to study drug administration.
• • 4. Patients with prior androgen deprivation therapy or any other neoadjuvant agent.
• • 5. The investigator determines that there are any medical diseases or other conditions that affect the safety or compliance of the subjects.