Metastatic castration-resistant prostate cancer
Conditions
Interventions
Experimental group:225Ac-PSMA-CY313, 200 µCi (±10%)/time, intravenously.The total dose of the whole treatment does not exceed 4 cycles, and 8 weeks (± 1 week) is 1 cycle, and each cycle is administere
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects are eligible for inclusion in the study only if they meet all of the following criteria: 1. Signed informed consent; 2. Male aged 18 years and above; 3. Histopathological and/or cytologically confirmed adenocarcinoma of the prostate; 4. ECOG physical status assessment level 0~2; 5. Serum/plasma testosterone must achieve castration levels (<1.7 nmol/L or <50 ng/dL) to participate in this trial, and subjects who have not been surgically castrated agree to continue ADT treatment to maintain serum testosterone at castration levels; 6. Prior anti-tumor therapy requirements: Group A: Patients with metastatic castration-resistant prostate cancer (mCRPC) who have received = 1 line of novel endocrine therapy (ARPI) and have progressed after receiving at least 1 but no more than 2 paclitaxel regimens, and have not received targeted radionuclide therapy; Group B: patients with mCRPC who have progressed after prior treatment with 177Lu-PSMA; Group C: mCRPC patients who have progressed after receiving =1 line of new endocrine therapy, have not received paclitaxel-containing regimens, and have not received targeted radionuclide therapy; 7. Presence of at least 1 metastatic measurable lesion in screening/baseline CT, MRI or bone scan scintigraphy obtained within 28 days prior to enrollment; 8. The PET scan result of 18F-PSMA-313 (or other PSMA imaging agent labeled with 64Cu is positive) (the SUVmax of the lesion is greater than the SUVmax of the liver), which is judged by the investigator to meet the requirements; 9. Proper organ function: a) Bone marrow reserve: white blood cell count (WBC) = 2.5×109/L, neutrophil count (NEUT) = 1.5×109/L, platelet (PLT) = 100×109/L, hemoglobin (HGB) = 80 g/L; b) Liver function: total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) both = 3.0×ULN; c) Renal function: creatinine clearance (CrCl) =50 mL/min (Cockcroft-Gault formula); d) Albumin (ALB): =30 g/L. 10. Clinically significant toxicities related to prior therapy must have recovered to Grade =2 (except alopecia); 11. For patients of childbearing potential: during the study and 6 months after the last dose of study drug, the partner and/or patient must use a method of contraception with adequate efficacy; 12. Willing and able to comply with all study requirements and treatments and cooperate with study visits.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study: 1. Prostate cancer with a known significant (>10% cell present) sarcomatoid and/or spindle cell components and/or neuroendocrine cells as shown by pathological findings; 2. Received local radiation therapy, chemotherapy, novel endocrine therapy (ARPI), bone-targeted therapy (such as denosumab, zoledronic acid), immunotherapy, biological therapy, investigational drug therapy within 28 days or 5 half-lives (whichever is longer) before the administration of the trial drug, and major surgery within 28 days before the administration of the trial drug; 3. Subjects in groups A and C have received targeted radionuclide therapy in the past, and subjects in group B have received other targeted radionuclide therapy other than 177Lu-PSMA in the past. 4. Bone scan showing super bone scintigraphy, which is defined as the uniformity and significant concentration of radioisotope uptake in the bones of the whole body relative to the soft tissues, and the urinary system is not developed or mildly developed; 5. Symptomatic spinal cord compression, or clinical or imaging suggestive of imminent spinal cord compression; 6. Presence of urinary tract obstruction; 7. Plan to combine cytotoxic chemotherapy, immunotherapy, biological therapy, radioligand therapy outside this trial, PARP inhibitors or other investigational treatments; 8. Life expectancy < 6 months as assessed by the investigator; 9. Have a history of central nervous system (CNS) metastases, and the nervous system is unstable, symptomatic, or requires glucocorticoids to maintain neurological stability; 10. History of other malignant tumors (except for patients who have been given adequate treatment and have survived without treatment for more than 3 years without recurrence, and patients with skin cancer and superficial bladder cancer who have been adequately treated for non-melanoma); 11. History of physical or psychiatric illness that may interfere with the purpose and evaluation of the study, or the investigator judges that the patient has any condition that is unable to cooperate with imaging examinations, treatments, and procedures; 12. Concomitant serious medical condition as assessed by the investigator, including, but not limited to, NYHA Class III or IV congestive heart failure, unstable ischemia, uncontrolled symptomatic arrhythmia, history of congenitally prolonged QT syndrome, uncontrolled infection, known active hepatitis B or C, or other significant illness that, in the opinion of the investigator, would impair study participation or collaboration; 13. Known hypersensitivity, hypersensitivity or intolerance to any of the study treatments or their excipients or similar chemical class drugs; 14. Other conditions that are considered inappropriate by the investigator to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radioactivity concentration values for each organ;SUVmax;Absorbed Dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Whole Body Effective Dose; | — |
Countries
China
Contacts
Public ContactSuping Li
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed