Metastatic castration-resistant prostate cancer
Conditions
Interventions
Test group:The initial dose for administration of 161Tb-NYM032 is set at 30mCi, with increasing doses ranging from 30 to 50, 80 to 130, and 200, with the highest dose not exceeding 200mCi.
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. The subject voluntarily signed the informed consent form, and could complete the test according to the requirements of the protocol; 2. Over 18 years old, male; 3. Metrized metastatic castration-resistant prostate cancer according to PCWG 3 standard; 4. 68 Ga-NYM032 positron emission tomography (PET) / computed tomography (CT) scan results showed positive results; 5. Patients with metastatic castration-resistant prostate cancer who have received at least one NAAD treatment (such as enzalutamide and / or abiraterone) or at least one taxane regimen or who cannot tolerate or refuse taxane; 6. The ECOG score is 0-2 points; 7. Expected survival period of 6 months; 8. Laboratory indicators should meet: a. ALT and AST shall not exceed 3 times normal limit, BUN and Cr shall not exceed 1.5 times normal limit; b. blood routine: WBC 3.5 * 10^9 / L, PLT 100 * 10^9 / L, Hb 90g / L.
Exclusion criteria
Exclusion criteria: 1. Recovery from a major trauma (including surgery) within 4 weeks prior to receiving the study treatment; 2. Patients with systemic or local severe infection or other serious coexisting diseases; 3. Patients with abnormal immune function or patients who have recently used immunosuppression or enhancers, including various vaccines; 4. Patients with autoimmune diseases, including rheumatoid disease; 5. Inadequate control of cardiac arrhythmia, including atrial fibrillation; 6. Cardiac insufficiency (> New York Heart Association (NYHA) Class II standard); 7. suffering from uncontrolled hypertension; 8. Patients with a history of antibody allergy or allergy to any component of the imaging agent; 9. Subjects positive for syphilis, HBV, HCV, and HIV; 10. Subjects of childbearing age cannot take effective contraceptive measures; 11. Patients with mental illness or related medical history; 12. Patients who are unable or unable to perform a SPECT / CT scan; 13. Patients who cannot retain urine for 30 minutes; 14. other subjects considered unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events/Serious Adverse Events; | — |
Secondary
| Measure | Time frame |
|---|---|
| PSA50 Remission rate;PSA90 Remission rate;Time to PSA progression;Disease control rate;Duration of remission;Radiographically progression-free survival;vital signs; | — |
Countries
China
Contacts
Public ContactZhengguo Chen
Mianyang Central Hospital
Outcome results
None listed