Imaging test for suspected recurrence of prostate cancer

A Phase III, Prospective, Open-Label, Single-Arm, Multi-center Clinical Study to Assess the Diagnostic Performance and Safety of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

This study is testing a new imaging technique to see if it can better detect prostate cancer recurrence in patients who are worried their cancer has come back.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 131 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: HTA Co., Ltd. (industry)
• Drugs / interventions: radiation
• Locations: 1 site (Guangzhou)
• Trial ID: NCT06754085 on ClinicalTrials.gov

What this trial studies

This study evaluates the use of 18F-Florastamin PET/CT imaging in patients who have suspected recurrence of prostate cancer. It aims to assess the diagnostic performance and safety of this imaging technique in identifying cancer recurrence or metastasis. Participants will receive an injection of Florastamin[18F] and undergo PET/CT scans to gather data on the effectiveness of this approach. The study is designed to provide insights into how well this imaging can detect prostate cancer recurrence compared to traditional methods.

Who should consider this trial

Good fit: Ideal candidates are males aged 18 and older with a confirmed diagnosis of prostate adenocarcinoma who show signs of suspected recurrence.

Not a fit: Patients without a confirmed diagnosis of prostate cancer or those who do not exhibit signs of recurrence may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of diagnosing prostate cancer recurrence, leading to better treatment decisions for patients.

How similar studies have performed: Other studies have shown promising results with similar imaging techniques, suggesting potential for success in this approach.

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 ≥ 18 years of age.
3. Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
4. Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:

   1. 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
   2. Post-radiation therapy, after radical radiotherapy (or cryoablation therapy): Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir .
5. Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
6. ECOG score 0 or 2.
7. Subjects who meet the following conditions in hematology, renal function, and liver function:

   Platelet count\>50 \* 10\^9/L Urea/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 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. If previously taking ADT, it should have been discontinued at least 16 weeks prior to study drug administration.
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