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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Florastamin Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florastamin[18F] Injection | Drug | The subjects will be intravenously injected with a single dose of 7±1 mCi (259±37 MBq) of Florastamin[18F] Injection and undergo PET/CT scan at 60-110 min after the injection. |
| Measure | Description | Time Frame |
|---|---|---|
| The Positive Predictive Value of 18F-Florastamin PET/CT in patients with suspected recurrence of prostate cancer on a patient-level. | 9 months |
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Inclusion Criteria:
Subjects fully understood the content, process, and potential risks of the study and voluntarily signed an informed consent form (ICF).
Male ≥ 18 years of age.
Histopathologically confirmed prostate adenocarcinoma per original diagnosis, with subsequent definitive therapy.
Suspected recurrence or distant metastasis of prostate cancer based on any of the following conditions:
Subjects who are willing to undergo biopsy, salvage surgery, or radiation therapy based on the researcher's clinical judgment;
ECOG score 0 or 2.
Subjects who meet the following conditions in hematology, renal function, and liver function:
Platelet count>50 * 10^9/L Urea/urea nitrogen and creatinine<1.5 times upper limits of normal AST and ALT<2.5 times upper limits of normal.
Expected survival time ≥ 6 months.
Subjects and their partners must use effective contraceptive measurements and avoid sperm donation from the date of signing ICF to 3 months after administration.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Fan | Contact | +86 13602883007 | fanwei@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | China |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |