Study of 18F-Florastamin PET/CT Imaging in Patients With 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

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Florastamin[18F] Injection

• Study Type: Interventional
• Enrollment (Estimated): 131
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Wei Fan; Phone Number: +86 13602883007; Email: fanwei@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Sun yat-sen University Cancer Center
    • Contact: Wei Fan; Phone Number: +8613602883007; Email: fanwei@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 18F-Florastamin Injection	Drug: Florastamin[18F] Injection; The subjects will be intravenously injected with a single dose of 7±1 mCi (259±37 MBq) of Florastamin[18F] Injection and undergo PET/CT scan at 60-110 min after the injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level.	9 months

Collaborators and Investigators

• Sponsor: HTA Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Disease Attributes; Prostatic Neoplasms; Recurrence
• Other Study ID Numbers: BJK-ZX-STM-2203-GK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No