Pathologically confirmed prostate cancer
Conditions
Interventions
Control Group:4(± 0.5)mCi(148±18.5 MBq)
Experimental group:6(± 0.5)mCi(222±18.5 MBq).
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Able to understand and sign the informed consent form; 2.Willing and able to comply with all study requirements and treatments, and cooperate with study visits; 3.Male aged 18 years and above; 4.Histopathologically and/or cytologically confirmed adenocarcinoma of the prostate; 5.Patients confirmed as PSMA-positive by central readers based on PET/CT scans with 68Ga-PSMA-11 or other marketed PSMA diagnostic reagents; 6.Patients with a history of radical prostatectomy or curative-intent radiotherapy; 7.Meeting the definition of disease recurrence, i.e.: a) Post radical prostatectomy, PSA > 0.2 ng/mL is documented; or b) Serologic/plasma PSA progression, defined as two consecutive PSA elevations (measured at an interval of at least 1 week) with a minimum starting value of 2.0 ng/mL; 8.At least one extraprostatic metastatic lesion confirmed by prior imaging or biopsy; 9.Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 10.Expected survival of more than 6 months; 11.Clinically significant adverse events from prior treatments (e.g., chemotherapy, radiotherapy, immunotherapy, etc.) have resolved to Grade =3.0×10^9/L or absolute neutrophil count (ANC) >=1.5×10^9/L; Platelet (PLT) count >=100×10^9/L; Hemoglobin (HGB) >=90 g/L. b) Hepatic function: Total bilirubin (TBIL) =50 mL/min/1.73m^2 (calculated based on the 2021 CKD-EPI formula). a)d) Albumin (ALB) >=30 g/L. 13.For patients with reproductive potential: The patient and/or their sexual partner(s) must use a sufficiently effective method of contraception during the study and for 3 months after the last administration of the study drug, which is deemed acceptable by the investigator.
Exclusion criteria
Exclusion criteria: 1.Received any PSMA-targeted immunotherapy or biotherapy (including antibodies) within 60 days prior to study drug administration; 2.Participated in any other clinical trial or received investigational drugs within 28 days prior to study drug administration or 5 half-lives (whichever is longer); 3.Known hypersensitivity, hypersensitive reaction or intolerance to any study treatment, its excipients, or drugs of the same chemical class; 4.Received blood transfusion for the purpose of meeting the eligibility criteria; 5.Patients with uncontrolled or untreated (surgery, radiotherapy, gamma knife) central nervous system (CNS) metastases; or with unstable disease, symptomatic metastases, or metastases requiring symptomatic treatment with glucocorticoids or mannitol, or metastases at critical anatomical sites. Exclusion does not apply to patients with epidural, spinal canal or spinal cord metastases who have received effective treatment and are in stable condition with no neurological impairment; 6.superscan on bone scan, defined as uniform and marked radiotracer uptake in the whole-body skeleton relative to soft tissues, with absent or mild radiotracer uptake in the urinary system simultaneously; 7.Complicated with severe medical conditions, including but not limited to NYHA Class III or IV congestive heart failure, acute coronary syndrome, uncontrolled severe cardiac arrhythmia, history of congenital long QT syndrome, uncontrolled infection, known active hepatitis B or C, or other serious illnesses that the investigator deems would compromise study participation or compliance. 8.A history of other malignant neoplasms, except for patients with adequately treated malignant neoplasms who have been disease-free without treatment for more than 3 years prior to screening, or patients with adequately treated non-melanoma skin cancer or superficial bladder cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Radiation dosimetry;Pharmacokinetic (PK) characteristics;In vivo biodistribution; | — |
Countries
China
Contacts
Public ContactXiaoli Lan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed