prostate cancer
Conditions
Interventions
Experimental group 1:177Lu/225Ac-LNC1011
Sponsors
The Affiliated Hospital of Southwest Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patient is able to understand and voluntarily sign the approved informed consent form (ICF); 2) Age = 18 years; 3) Patients must have a histologic, pathologic and/or cytologic diagnosis of prostate cancer; 4) Expected survival = 6 months; 5) ECOG score = 2; 6) PSMA positivity confirmed by baseline 68Ga-PSMA PET/CT imaging; 7) Adequate bone marrow, liver, and renal function as defined below: a) white blood cells (WBC) = 2.5*109/L b) Platelets = 90*109/L c) hemoglobin = 9 g/dL d) Total bilirubin = 1.5 × the institutional upper limit of normal (ULN) e) ALT or AST = 3.0 x ULN or = 5.0 x ULN (liver metastases) f) Serum creatinine = 1.5 x ULN or creatinine clearance = 50 mL/min. 8) All other pre-existing toxicity grades need to be = NCI-CTCAE v5.0 Grade 0 or 1.
Exclusion criteria
Exclusion criteria: 1) Patients who have received nuclide therapy within 6 months; 2) Patients who have received chemotherapy, radiotherapy, immunotherapy, or clinical trial drugs within 28 days; 3) Patients who are allergic or hypersensitive to known components or excipients of the investigational drug; 4) patients who suffer from claustrophobia or are otherwise unable to tolerate imaging procedures 5) active infections of clinical significance, as determined by the investigator 6) have a pre-existing or current uncontrolled primary or metastatic tumor of the brain 7) a serious and/or poorly controlled and/or unstable other medical condition that, in the judgment of the investigator, may interfere with the study, including but not limited to: a) poorly controlled diabetes mellitus b) congestive heart failure c) myocardial infarction within the past 12 months d) unstable and uncontrolled hypertension e) Chronic kidney or liver disease f) severe lung disease 8) Subjects with poor compliance who are not expected to cooperate in completing the trial procedures; 9) Other subjects who, in the opinion of the investigator, are not suitable for participation in the clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Radiation dose to major organs and tumors; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Progression-Free Survival;Changes in PSA before and after treatment;Changes in tumor SUVs before and after treatment; | — |
Countries
China
Contacts
Public ContactChen Yue
The Affiliated Hospital of Southwest Medical University
Outcome results
None listed