Metastatic castration-resistant prostate cancer
Conditions
Interventions
The 50 mCi dose group:The safety, tolerability, and preliminary efficacy of 161Tb-PSMA in patients with metastatic castration-resistant prostate cancer
The 80 mCi dose group:The safety, tolerability, and preliminary efficacy of 161Tb-PSMA in patients with metastatic castration-resistant prostate cancer
The 130mCi dose group:The safety, tolerability, and preliminary efficacy of 161Tb-PSMA in patients with metastatic castration-resistant prostate cancer
The 200mCi dose group:The safety, tolerability, and preliminary efficacy of 161Tb-PSMA in patients with metastatic castration-resistant prostate cancer
Sponsors
Mianyang Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily sign the informed consent and are able to complete the trial in accordance with the requirements of the protocol; 2. aged 18 years old or above, male; 3. metastatic desmoplasia-resistant prostate cancer as determined by PCWG3 criteria; 4. have a positive 68Ga-PSMA positron emission tomography (PET)/computed tomography (CT) scan; 5 .Patients with metastatic desmoplasia-resistant prostate cancer who must have been treated with at least one NAAD therapy (e.g., enzalutamide and/or abiraterone, etc.) or at least one paclitaxel regimen or who are intolerant of or refuse paclitaxel; 6 .ECOG score of 0-2; 7. expected survival >= 6 months; 8. Laboratory parameters to be met: a. ALT, AST must not exceed 3 times the upper limit of normal value, BUN, Cr does not exceed 1.5 times the upper limit of normal value; 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 ll 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 |
|---|---|
| vital signs;PSA50 Remission rate;PSA90 Remission rate;Radiographically progression-free survival;Duration of remission;Disease control rate;Time to PSA progression; | — |
Countries
China
Contacts
Public ContactZhengguo Chen
Mianyang Central Hospital
Outcome results
None listed