Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07115277
NA

Diagnostic Efficacy and Safety of Flotufolastat F-18 Injection in Subjects With Biochemical Recurrence of Prostate Cancer

Sponsor: Sinotau Pharmaceutical Group

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the diagnostic performance and safety of Flotufolastat F-18 injection PET imaging in prostate cancer subjects with biochemical recurrence following prior treatment. The main question it aims to answer is: • What is the correct detection rate of Flotufolastat F 18 injection PET visual reading results compared to the truth standard? Participants will: * Receive Flotufolastat F-18 injection * Undergo PET/CT scanning

Official title: A Single-arm, Multicenter, Phase III Clinical Trial , Evaluate the Diagnostic Performance and Safety of Flotufolastat F-18 Injection PET Imaging in Prostate Cancer Subjects With Biochemical Recurrence Following Prior Treatment

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

121

Start Date

2025-03-14

Completion Date

2026-12-31

Last Updated

2025-08-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

Flotufolastat F-18 Injection

All patients will receive one injection of Flotufolastat F-18 Injection, a PET radiopharmaceutical selective for PSMA. For the injection, subjects will receive a target dose of 8 mCi (296 MBq) ± 20% IV as a bolus injection. Flotufolastat F-18 Injection will be followed by a 10 ml saline flush.

Locations (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China