Prostate Cancer
Conditions
Interventions
Group B:64Cu-PSMA-617 PET/CT. Two weeks later, 64Cu-TR2205 PET/CT was performed
Group A:64Cu-TR2205 PET/CT. Two weeks later, 64Cu-PSMA-617 PET/CT was performed
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Before participating in the research, it is necessary to obtain the signed informed consent form. 2.Male patients aged 18 or above. 3. Prostate cancer confirmed by histology or cytology. 4. Metastatic hormone-sensitive prostate cancer (mHSPC) or metastatic castration-resistant prostate cancer (mCRPC) confirmed or suspected by routine imaging examinations, with a high-risk initial diagnosis (Gleason score >=8) : at least one metastasis in bone and/or soft tissue/visceral sites is confirmed or suspected: a. Baseline bone metastases at any site were shown by 99mTc-MDP bone scan imaging or other examinations. And/or b. Lymph node metastases of any size or distribution; And/or c. Visceral transfers of any size or distribution. Patients with primary lesions, liver metastases, or retroperitoneal metastases confirmed by routine imaging examinations will be given priority for enrollment. 5. The ECOG score is 0 to 2 points. 6. Have sufficient organ function and bone marrow reserve: Neutrophil count (ANC) >= 1.5×10^9/L, platelet count >=100×10^9/L, hemoglobin >=90g/L; Liver: Total bilirubin (TBIL) <=1.5 times the upper limit of normal value (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3.0×ULN; Kidney: Serum creatinine (SCr) <=1.5×ULN.
Exclusion criteria
Exclusion criteria: 1.Prior PSMA-targeted radioligand therapy (RLT). 2.Currently participating in any other clinical trial or receiving investigational drugs. 3.Patients with a medical history of superscan on bone scintigraphy (defined as: diffuse, homogeneous radiotracer uptake throughout the skeleton with markedly increased bone-to-soft tissue ratio, accompanied by absent or faint urinary tract activity). 4.Patients with symptomatic CNS metastases or those requiring corticosteroids to maintain neurological function. 5.History of concurrent malignancies (except those adequately treated with no recurrence for =3 years, or adequately treated non-melanoma skin cancer/superficial bladder cancer). 6.Presence of severe or poorly controlled medical conditions, including but not limited to: Uncontrolled infections (e.g., severe or prolonged COVID-19 infection with incomplete recovery) Known active hepatitis B or C infection Any other condition that, in the investigator's judgment, may compromise study participation or protocol compliance. 7.History of physical or psychiatric conditions that may interfere with study objectives or evaluations, or any circumstance deemed by the investigator to potentially compromise compliance with imaging procedures or study operations. 8.Patients unwilling to use effective contraception or practice abstinence during the study period. 9.Other conditions deemed by the investigator to render the patient unsuitable for trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kinetic Parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Endpoints;Radiation Absorbed Dose;Delayed Imaging Efficacy; | — |
Countries
China
Contacts
Public ContactBin Zhang
The First Affiliated Hospital of Soochow University
Outcome results
None listed