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The Clinical Efficacy of [F-18]Florastamin PET/CT for Initial Staging and Relapsed Restaging in Prostate Cancer: A Single-Center Prospective Pilot Study

The Clinical Efficacy of [F-18]Florastamin PET/CT for Initial Staging and Relapsed Restaging in Prostate Cancer: A Single-Center Prospective Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0009634
Enrollment
55
Registered
2024-07-11
Start date
2023-10-16
Completion date
Unknown
Last updated
2024-07-23

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

Conditions

None listed

Interventions

Drug : Only for clinical trial subjects who meet the selection/exclusion criteria, '[F-18]Florastamin' of 370±37 MBq (10±1 mCi) is injected intravenously once at visit 2. Care should be taken to preve

Sponsors

Soon Chun Hyang University Hospital Seoul
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Among male patients over 19 years of age (No. 1 and No. 2 are either) 1. Early Prostate Cancer Patients - First patient diagnosed with prostate cancer by performing biopsy 2. a group of suspected prostate cancer relapses - Patients suspected of recurrence after radical treatment of prostate cancer are defined as cases in which PSA levels continue more than twice in a row after radical prostatectomy, or when PSA levels increase by more than 2 ng/ml during follow-up after radiotherapy (RT). 3. Subjects who have been fully explained by the clinical trial manager and clinical trial officer about the purpose, content, characteristics of clinical trial drugs, etc. before registering for a clinical trial, and signed the consent form by themselves or their guardians or legal representatives

Exclusion criteria

Exclusion criteria: 1. A person who has been diagnosed with or treated for carcinoma other than prostate cancer within five years from the time of screening 2. A person currently being treated for severe cardiovascular system, respiratory system, biliary system, kidney and urinary system, infectious disease, etc 3. A person who has a hypersensitivity reaction to radioactive drugs and contrast agents 4. A person who is difficult to lie still for 30 to 60 minutes due to a superfine position (e.g., panic disorder or claustrophobia) or who is determined by the clinical trial director to have a mental illness that is difficult to photograph in relation to the radiographic examination (CT, MRI) 5. A person who has participated in other clinical trials from the time of registration to the end of this clinical trial 6. Vulnerable subjects (the clinical trial manager himself or his/her family participating in the clinical trial or the researcher or student of the clinical trial manager participating in the clinical trial or the family of the subject) 7. A person deemed unfit to participate in this clinical trial based on the medical findings of the clinical trial manager

Design outcomes

Primary

MeasureTime frame
Abdomen CT, Chest CT, Pelvic MRI(or prostate dynamic MRI), bone scan;Differences in clinical efficacy divided into diagnosis and recurrence times

Secondary

MeasureTime frame
Evaluation of Abnormal Cases and Vital Signs

Countries

Korea, Republic of

Contacts

Public ContactChae Hong Lim

Soon Chun Hyang University Hospital Seoul

100819@schmc.ac.kr+82-2-709-7333

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026