Clinical utility of [F-18]PSMA-1007 PET/CT (positron emission tomography/computed tomography) in evaluating preoperative staging of prostate cancer before radical prostatectomy

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0004476
• Lead Sponsor: Yonsei University Health System, Severance Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-03-05
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 126

Inclusion Criteria

1. Inclusion Criteria
(1) An adult male aged 20 years or older who is planning to undergo radical prostatectomy for intermediate to high risk prostate cancer.
(2) The subject can and will follow the clinical trial procedure, and the subject obtains a signed and dated patient consent.

Exclusion Criteria

2. Exclusion Criteria
(1) Patients who do not agree with the study
(2) Patients with hypersensitivity to radioisotopes
(3) Participants in other studies at the time of screening who may influence [F-18] PSMA-1007 image acquisition.
(4) A person deemed difficult to conduct a clinical trial due to a serious medical condition by the researcher.
(5) Those who have had a mental illness that is difficult to scan PET/CT.
(6) Vulnerable subjects (researchers or students involved in the research, researchers or students of the researchers involved in the research, the family of the subjects)
(7) Other investigator determined to be unsuitable for participation in this clinical trial
(8) Those who were found to be difficult to remove surgically on the areas that appeared positive on PET imaging.

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the diagnosis of staging by comparing the [F-18]PSMA-1007 PET/CT and CT, MRI, whole body bone scan (WBBS), FDG PET/CT during staging before prostate cancer surgery.

Secondary Outcome Measures

Name	Time	Method
[F-18] PSMA / positive emission tomography / computed tomography (PET / CT) was used to establish staging prior to prostate cancer surgery after [F-18] PSMA-1007 intravenous injection. Comparative evaluation of staging diagnosis results compared with CT.