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

In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.

This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 267
• 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 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.

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: [18F]Florastamin Injection; The subjects who participate in phase 3 study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 110 min after the injection. Subjects who participate in pilot study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology. The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study.	Within 28 days following 18F-Florastamin PET/CT

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity	The sensitivity of 18F-Florastamin PET/CT in patients with positive pelvic lymph node metastasis compared with the histopathology.	Within 28 days following 18F-Florastamin PET/CT

Collaborators and Investigators

• Sponsor: HTA Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: BJK-ZX-STM-2202-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