Prostate Cancer
Conditions
Brief summary
This is a single arm study to evaluate the safety and biodistribution of 177Lu-labeled NY108 (177Lu-NY108) SPECT Imaging in patients.
Interventions
DRUG177Lu-labeled NY108
Patients will receive a tracer (40-60ug) dose of 177Lu(28.5-31.5mCi) labelled NY108.
Sponsors
Affiliated Hospital of Jiangnan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients voluntarily signed informed consent; 2. Age 18-75, male; 3. Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy and at least one metastasis; 4. Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive; 5. Patients must have received at least one NAAD (such as enzalutamide and/or abiraterone) and at least one paclitaxel regimen; 6. Progressive metastatic destructive resistant prostate cancer as determined by PCWG3 criteria; 7. An ECOG score of 0-2
Exclusion criteria
1. Recovery from major trauma (including surgery) within 4 weeks prior to study treatment; 2. Patients with severe systemic or localized infections or other serious coexisting diseases; 3. Patients with abnormal immune function or who have recently used immunosuppressive or booster agents including various vaccines, etc; 4. Patients with autoimmune diseases, including rheumatoid, etc; 5. Inadequately controlled arrhythmias, including atrial fibrillation: 6. Cardiac insufficiency (New York Heart Association (NYHA) work class criteria); 7. Uncontrolled hypertension; 8. Patients with a history of allergy or hypersensitivity to any component of the imaging agent, including antibodies; 9. Subjects positive for syphilis, HBV, HCV, FIIV; 10. Subjects of childbearing age who are unable to use effective contraceptive devices: 11. Patients with a history of mental illness or related medical conditions; 12. Patients who are unable or unavailable for SPECT/CT scanning; 13. Other subjects who, in the opinion of the investigator, are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of tissue distribution of 177Lu-Anti-PSMA mAbs(NY108) | 1 year | Biodistribution of 177Lu-Anti-PSMA mAbs(NY108) evaluated by radioactive uptake values (standardized uptake values, SUVs) in various organs during repeated 177Lu-SPECT scans will be reported. |
| Incidence of Treatment-Emergent Adverse Events | 1 year | Safety will be assessed by evaluation of incidence of adverse events. |
Countries
China
Contacts
Primary ContactChunjing Yu
Outcome results
None listed