Prostate Cancer
Conditions
Brief summary
This study aims to evaluate the imaging characteristics of \[⁶⁸Ga\]Ga-GS24-B2-250-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-250-T), \[⁶⁸Ga\]Ga-GS24-B2-268-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-268-T), \[⁶⁸Ga\]Ga-GS24-B2-237-T Injection (abbreviated as ⁶⁸Ga-GS24-B2-237-T), and \[⁶⁸Ga\]Ga-PSMA-11 Injection (abbreviated as ⁶⁸Ga-PSMA-11) as PET/CT imaging agents in patients with prostate cancer.
Interventions
DIAGNOSTIC_TEST68Ga-GS24-B2-268-T
detect prostate cancer lesions via 68Ga-GS24-B2-268-T PET/CT imaging
DIAGNOSTIC_TEST68Ga-GS24-B2-250-T
detect prostate cancer lesions via 68Ga-GS24-B2-250-T PET/CT imaging
DIAGNOSTIC_TEST68Ga-GS24-B2-237-T
detect prostate cancer lesions via 68Ga-GS24-B2-237-T PET/CT imaging
DIAGNOSTIC_TEST68Ga-PSMA-11
detect prostate cancer lesions via 68Ga-PSMA-11 PET/CT imaging
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has fully understood the trial content, process, and potential risks, and has voluntarily signed the informed consent form; 2. Male subjects aged ≥ 18 years; 3. Clinically or radiologically assessed as metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC); 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2; 5. Presence of positive lesions on ⁶⁸Ga-PSMA-11 PET/CT scan; 6. Blood routine, renal function, and liver function tests meeting the following criteria: 1. Platelet count \> 90 × 10⁹/L; 2. Urea/urea nitrogen and serum creatinine \< 1.5 × upper limit of normal (ULN); 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5 × ULN; 7. Expected survival time ≥ 6 months; 8. From the date of signing the informed consent form until 3 months after administration, the subject and his partner must use effective contraceptive measures, and the subject must avoid sperm donation.
Exclusion criteria
1. Having participated in another interventional clinical trial prior to signing the informed consent form and being within 5 half-lives of the investigational product of that trial; or currently participating in another interventional clinical trial; or having participated in a clinical trial involving radiopharmaceuticals prior to signing the informed consent form with an interval of less than 3 months between the last dose and the informed consent signing date. 2. Having received any intravenous iodine-containing contrast agent within 24 hours prior to administration, or any high-density oral contrast agent (e.g., barium sulfate) within 5 days prior to administration. Oral water-soluble contrast agents (e.g., compound meglumine diatrizoate oral solution) are acceptable. 3. Having received high-energy γ-ray-emitting agents (\>300 KeV, e.g., radiopharmaceuticals labeled with radionuclides such as \[¹³¹I\]I, \[¹⁸F\]F, \[⁶⁸Ga\]Ga, \[⁶⁴Cu\]Cu, etc.) within a period equivalent to either 5 half-lives of the agent or 2 days, whichever is longer, prior to administration. 4. Planning to adjust anti-tumor medication during the study period. 5. Being unable to complete the required PET/CT imaging procedures. 6. Having any medical condition or other circumstances that, in the investigator's judgment, may affect the safety or compliance of the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Standardized Uptake Value for major organs (salivary glands, kidneys, bone marrow, etc.) and tumor lesions (primary and metastatic lesions) | 5 days | The Standardized Uptake Value (SUVmax and SUVmin) of major organs (salivary glands, kidneys, bone marrow, etc) and tumor lesions (primary and metastatic lesions) is measured by using Positron Emission Tomography/Computed Tomography (PET/CT) imaging technology for both 68Ga-PSMA-11 and other tested tracers. |
Outcome results
None listed