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[18F]Florastamin PET/CT Imaging Examination in Patients With Suspected Recurrent or Metastatic Prostate Cancer

NCT05936658 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2025-03-12

No results posted yet for this study

Summary

This is a multi-center, open-label, single arm Phase III clinical trial for the diagnostic efficacy assessment and safety evaluation by \[18F\]Florastamin PET/CT imaging examination to determine the presence of recurrent or metastatic prostate cancer in patients whose recurrent or metastatic lesions have been confirmed through the conventional imaging.

Conditions

  • High Risk Prostate Carcinoma

Interventions

DRUG

[F-18]Florastamin

A single dose of \[F-18\]Florastamin at 10 ± 1 mCi is intravenously administered only to the subjects who meet the inclusion/exclusion criteria, and then \[F-18\]Florastamin PET/CT imaging is performed from the head to thigh after 105 ± 15 minutes (care should be taken to prevent extravasation of the radiopharmaceutical product).

Sponsors & Collaborators

  • FutureChem

    lead INDUSTRY

Principal Investigators

  • Jae Young Joung, Ph.D · National Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-08
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • South Korea

Study Locations

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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 NCT05936658 on ClinicalTrials.gov