Using 18F-Florastamin PET/CT Imaging for Intermediate Risk Prostate Cancer

A Phase III, Open-Label, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer

This study is testing if a new type of imaging called 18F-Florastamin PET/CT can help doctors better identify and understand prostate cancer in men with intermediate risk who are about to have surgery.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 267 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: HTA Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06011304 on ClinicalTrials.gov

What this trial studies

This study evaluates the diagnostic performance and safety of 18F-Florastamin PET/CT imaging in patients diagnosed with at least intermediate risk prostate cancer. It involves a pilot study that includes assessments of pharmacokinetics and radiation dosimetry. The goal is to determine how effectively this imaging technique can identify and assess prostate cancer in patients scheduled for radical prostatectomy and pelvic lymph node dissection.

Who should consider this trial

Good fit: Ideal candidates are male patients aged 18 or older with a histopathological diagnosis of prostate adenocarcinoma and at least intermediate risk factors.

Not a fit: Patients with low-risk prostate cancer or those who do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of prostate cancer diagnosis and treatment planning for patients.

How similar studies have performed: Other studies have shown promising results with similar imaging approaches, indicating potential for success.

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.

Where this trial is running

Guangzhou

• Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)

Study contacts

• Study coordinator: Wei Fan

Conditions Prostate Cancer