Changes in 18F-NaF PET/CT and 18F-FDG PET/CT after 223Ra Dichloride Treatment in Patients With Castration-Resistant Prostate Cancer with Osseous Metastases
- Conditions
- Neoplasms
- Registration Number
- KCT0002899
- Lead Sponsor
- Korea Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
1. Histologically diagnosed prostate cancer patient
- previous surgical or chemical castration with serum testosterone <50 ng / dL
- Persons who continue to use LHRH agonists during clinical trials if the castration method is a luteinizing hormone-releasing hormone (LHRH) agonist.
- Prostate Serum Antigen (PSA) = 5 ng / mL
- Clinically diagnosed with castration-resistant prostate cancer
- Those with radiographic evidence of at least two measurable bone metastases (radionuclide bone scan, CT scan or MRI)
2. Able to provide informed consent and have signed an approved consent form that conforms to institutional guidelines to ensure compliance
3. Men with age =/> 19 years and =/<80 years
4. ECOG _ Performance scale =2
5. Life expectancy of greater than or equal to 6 months.
6. Those who satisfy the following conditions in blood test
- Absolute neutrophil count (ANC) = 1,500 / µL
- Platelet count (PLT) = 100,000 / µL
- Hemoglobin = 10 g/dL (100 g/L; 6.2 mmol/L)
1. A person who is judged to be difficult to perform a clinical trial due to a serious medical condition
2. Visceral metastases as assessed
3. Lymphadenopathy exceeding 3 cm in short-axis diameter
4. The person who is determined to have a mental disorder that is difficult to perform PET (Positron Emission Tomography) scan
5. Those participating in other clinical trials at screening and participating in clinical trials should be able to influence the acquisition of 18F-fluorodeoxyglucose or 18F-NaF PET images (For example, if you are participating in another cohort-based trial that is simply focused on monitoring that you do not receive medicines during screening, you can participate in the current clinical trials.)
6. Those who participated in other clinical trials that may affect the acquisition of 18F-FDG or 18F-NaF PET (Positron Emission Tomography) images from the time of registration until the end of the study, or that may affect the safety assessment following intravenous injection of 223Ra dichloride
7. Those who are likely to influence the acquisition of 18F-fluorodeoxyglucose PET (Positron Emission Tomography) imaging due to unadjusted diabetes
8. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.
9. Vulnerable subjects (researchers or students who participated in research, family members, researchers or students of researchers participating in research)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method standardized uptake value (SUV) of 18F-NaF PET;standardized uptake value (SUV) of 18F-FDG PET
- Secondary Outcome Measures
Name Time Method PSA (prostate specific antigen);ALP (alkaline phosphatase)