Actively Recruiting

Phase 3
Age: 18Years +
MALE
NCT06754085

Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

Led by HTA Co., Ltd. · Updated on 2024-12-31

131

Participants Needed

1

Research Sites

71 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Study of 18F-Florastamin PET/CT Imaging in Patients With Suspected Recurrence of Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Male aged 18 years or older
  • Histopathologically confirmed prostate adenocarcinoma with prior definitive therapy
  • Suspected recurrence or distant metastasis of prostate cancer based on PSA criteria after radical prostatectomy or radiation therapy
  • Willingness to undergo biopsy, salvage surgery, or radiation therapy as clinically needed
  • ECOG performance status of 0 or 2
  • Adequate blood counts and normal kidney and liver function within specified limits
  • Expected survival of at least 6 months
  • Use of effective contraception and avoidance of sperm donation from consent until 3 months post administration
Not Eligible

You will not qualify if you...

  • Participation in other interventional clinical trials within specified washout periods
  • Intravenous iodinated contrast within 24 hours or high-density oral contrast within 5 days before study drug administration
  • Prior use of high energy gamma-emitting radioisotopes within five physical half-lives before study drug administration
  • Use of androgen deprivation therapy within 16 weeks prior to study drug administration
  • Any medical conditions or other factors that may affect safety or compliance as determined by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, China

Actively Recruiting

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Research Team

W

Wei Fan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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