RecruitingNot ApplicableNCT07115277

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

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


Sponsor

Sinotau Pharmaceutical Group

Enrollment

121 participants

Start Date

Mar 14, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing the diagnostic accuracy and safety of a radioactive PET scan tracer called Flotufolastat F-18 (XTR020), which targets a protein found on prostate cancer cells (PSMA). It is being studied in men whose PSA levels have risen again after initial prostate cancer treatment, suggesting the cancer may have returned. **You may be eligible if...** - You are male, 18 or older - You have previously been treated for prostate cancer (surgery, radiation, or other local therapy) - Your PSA level has risen in a way that suggests cancer recurrence - You are willing to follow up with a biopsy or additional imaging if a lesion is detected **You may NOT be eligible if...** - You are planning to have another radioactive imaging scan within 24 hours before this study's PET scan - You are currently enrolled in an interventional clinical trial - You are unable to follow contraception requirements during the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFlotufolastat 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

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NCT07115277


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