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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004476

Enrollment

126

Registered

2019-11-27

Start date

2019-06-03

Completion date

Unknown

Last updated

2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others : PET / CT imaging was performed 90 minutes after intravenous administration of [F-18] PSMA-1007 injection in all subjects. [F-18] PSMA-1007 injection was administered at a rate of 0.25 mL / se

GE Healthcare, Milwaukee, WI, USA) were taken from the skeletal base to the upper thigh. After taking low dose (36mA, 120 kVp), PET images were taken in 3D form for 2.5 minutes per bed position, which

Eligibility

Sex/Gender

Male

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
[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.	—

Countries

Korea, Republic of

Contacts

Public ContactDongwoo Kim

Yonsei University Health System, Severance Hospital

kdwoo@yuhs.ac+82-2-2228-4852

Outcome results