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In this study, 18F-Florastamin PET/CT will be performed in patients with at least intermediate risk prostate cancer, to assess the diagnostic performance and safety of 18F-Florastamin PET/CT imaging.
This study will first carry out the pilot study (including pharmacokinetics and radiation dosimetry).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-Florastamin Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]Florastamin Injection | Drug | The subjects who participate in phase 3 study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 110 min after the injection. Subjects who participate in pilot study will be intravenously injected with [18F]Florastamin Injection and undergo PET/CT scan at 5 min, 30 min, 60 min, 110 min, 160 min after the injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity | The specificity of 18F-Florastamin PET/CT in patients with negative pelvic lymph node metastasis compared with the histopathology. The subjects underwent RP (radical prostatectomy) with PLND (pelvic lymph node dissection) within 28 days after the administration of 18F-Florastamin Injection. The histopathology results of the pelvic lymph node tissue collected from the subjects will be used as the standard of truth for this study. | Within 28 days following 18F-Florastamin PET/CT |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | The sensitivity of 18F-Florastamin PET/CT in patients with positive pelvic lymph node metastasis compared with the histopathology. | Within 28 days following 18F-Florastamin PET/CT |
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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 subjects aged 18 or older.
Subjects with histopathological diagnosis of prostate adenocarcinoma.
According to clinical judgment, radical prostatectomy and pelvic lymph node dissection (which can include patients with localized, regional lymph node metastasis or oligometastatic prostate cancer) are planned, and there is no surgical contraindication.
If it is localized prostate cancer, according to the Prostate Cancer Diagnosis and Treatment Guidelines of 2021 Chinese Society of Clinical Oncology, it is necessary to meet any of the following criteria:
Intermediate Risk: Has at least one intermediate risk factor: T2b-T2c; Gleason pattern 2 or 3; PSA 10-20 ng/mL, and does not include feature of high-risk or very-high-risk groups.
High Risk: Has no very-high-risk features and has at least one high-risk feature: T3a; Gleason Grade Group 4 or 5; PSA >20 ng/mL.
Very High Risk: Has at least one of the following: T3b-T4; Primary Gleason pattern 5; More than 4 punctures with Gleason Grade Group 4 or 5.
ECOG score 0 or 1.
Subjects who meet the following conditions in hematology, renal function, and liver function:
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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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |