Last updated: April 4, 2023
Sponsor: Affiliated Hospital of Jiangnan University
Overall Status: Active - Recruiting
Phase
1
Condition
Prostate Cancer
Urologic Cancer
Prostate Cancer, Early, Recurrent
Treatment
N/AClinical Study ID
NCT05815394
LS2023013
Ages 18-75 Male
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients voluntarily signed informed consent;
- Age 18-75, male;
- Clinical diagnosis of prostate cancer with diagnostic criteria referencing biopsy andat least one metastasis;
- Patients must be 68Ga-NY108 Positron Emission Tomography (PET)/Computed Tomography (CT) scan positive;
- Patients must have received at least one NAAD (such as enzalutamide and/orabiraterone) and at least one paclitaxel regimen;
- Progressive metastatic destructive resistant prostate cancer as determined by PCWG3criteria;
- An ECOG score of 0-2
Exclusion
Exclusion Criteria:
- Recovery from major trauma (including surgery) within 4 weeks prior to studytreatment;
- Patients with severe systemic or localized infections or other serious coexistingdiseases;
- Patients with abnormal immune function or who have recently used immunosuppressive orbooster agents including various vaccines, etc;
- Patients with autoimmune diseases, including rheumatoid, etc;
- Inadequately controlled arrhythmias, including atrial fibrillation:
- Cardiac insufficiency (New York Heart Association (NYHA) work class criteria);
- Uncontrolled hypertension;
- Patients with a history of allergy or hypersensitivity to any component of the imagingagent, including antibodies;
- Subjects positive for syphilis, HBV, HCV, FIIV;
- Subjects of childbearing age who are unable to use effective contraceptive devices:
- Patients with a history of mental illness or related medical conditions;
- Patients who are unable or unavailable for SPECT/CT scanning;
- Other subjects who, in the opinion of the investigator, are not suitable forenrollment.
Study Design
Total Participants: 10
Study Start date:
March 03, 2023
Estimated Completion Date:
December 12, 2024
Connect with a study center
Affiliated Hospital of Jiangnan University
Wuxi, Jiangsu 214000
ChinaActive - Recruiting
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