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

NCT07115277 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2025-08-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sinotau Pharmaceutical Group

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-14
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07115277 on ClinicalTrials.gov