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Trial Title:
Study of 18F-Florastamin PET/CT Imaging in Patients With at Least Intermediate Risk Prostate Cancer
NCT ID:
NCT06011304
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
[18F]Florastamin Injection
Description:
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.
Arm group label:
18F-Florastamin Injection
Summary:
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subjects fully understood the content, process, and potential risks of the study and
voluntarily signed an informed consent form (ICF).
2. Male subjects aged 18 or older.
3. Subjects with histopathological diagnosis of prostate adenocarcinoma.
4. 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.
5. 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.
6. ECOG score 0 or 1.
7. Subjects who meet the following conditions in hematology, renal function, and liver
function:
- Platelet count>100 * 10^9/L
- Urea nitrogen and creatinine<1.5 times upper limits of normal
- AST and ALT<2.5 times upper limits of normal.
8. Expected survival time ≥ 6 months.
9. 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:
1. Subjects who have participated in other interventional clinical trials before
signing ICF and were within the 5 half-lives of the investigational drug, or who are
currently participating in other interventional clinical trials or have participated
in clinical trials of radioactive drugs within 1 year before signing ICF and have
been discontinued for less than 3 months until the signing date of ICF.
2. Intravenous injection of iodinated contrast medium within 24 hours, or any
high-density oral contrast medium (Such as barium sulfate. Oral water contrast is
acceptable, such as compound meglumine diatrizoate oral liquid) within 5 days, prior
to study drug administration.
3. Subjects administered any high energy (>300 KeV) gamma-emitting radioisotope within
five physical half-lives prior to study drug administration.
4. Patients with prior androgen deprivation therapy or any other neoadjuvant agent.
5. The investigator determines that there are any medical diseases or other conditions
that affect the safety or compliance of the subjects.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Fan
Phone:
+8613602883007
Email:
fanwei@sysucc.org.cn
Start date:
October 20, 2023
Completion date:
January 2025
Lead sponsor:
Agency:
HTA Co., Ltd.
Agency class:
Industry
Source:
HTA Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06011304
