Prostate cancer
Conditions
Interventions
Dose group A:NC527-X: 0.01 mg/kg, administered by intravenous drip 2 to 72 hours before surgery.
Dose group B:NC527-X: 0.02 mg/kg, administered by intravenous drip 2 to 72 hours before surgery.
Dose group C:The dosing regimen is determined based on the results from Group A and Group B. If the imaging quality and TBR results of Group A are superior to those of Group B, the administration dose
otherwise, the dose will be 0.04 mg/kg. The method of administration remains the same as above.
Dose group D:The dosing regimen is determined based on the results from Group A, Group B, and Group C.
If Group A demonstrates the best imaging quality and TBR results, the administration dose will b
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed written informed consent; 2. Males aged 18-80 years; 3. Prostate cancer diagnosed by imaging and/or pathologically confirmed with stage cT2-cT4, Gleason score of 7-10 or International Society of Urological Pathology (ISUP) grade 2-5; 4. Planned radical prostatectomy (with or without enlarged pelvic lymph node dissection) (no contraindications to surgery as assessed by the investigator); 5. ECOG score is 0-1; 6. The subject uses effective contraceptive methods during the trial and continues to use contraception for 3 months after the end of the drug; 7. Able to understand the procedures and methods of this study, and willing to strictly abide by the clinical trial protocol to complete this trial.
Exclusion criteria
Exclusion criteria: 1. Voluntarily signed written informed consent; 2. Males aged 18-80 years; 3. Prostate cancer diagnosed by imaging and/or pathologically confirmed with stage cT2-cT4, Gleason score of 7-10 or International Society of Urological Pathology (ISUP) grade 2-5; 4. Planned radical prostatectomy (with or without enlarged pelvic lymph node dissection) (no contraindications to surgery as assessed by the investigator); 5. ECOG score is 0-1; 6. Subject accepts use during the trial 1. Previous allergy to similar products, contrast agents, fluorescent lamps or known allergy to this study drug and any other ingredients; 2. Enrollment in another clinical study (including observational or non-interventional clinical studies) within 1 month before the first dose; 3. Received live attenuated vaccine within 28 days before the first dose; 4. Major surgical procedure (as defined by the investigator) within 1 month before the first dose; 5. Subjects have received previous allogeneic stem cell or solid organ transplantation; 6. Adverse reactions caused by previous treatment within 28 days before the first dose that have not recovered to CTCAE 5.0 standard grade 1 or below (pigmentation, alopecia, adverse reactions assessed by the investigator without safety risk can be included); 7. Laboratory test results suggest that the subject does not have good organ function: 8. Primary central nervous system tumors or symptomatic central nervous system metastases (meningeal metastases should be excluded with or without symptoms); 9. Occurrence of the following cardiovascular disease within 6 months prior to the first dose: symptomatic heart failure with New York Heart Association Class (NYHA) grade 2 or above, left ventricular ejection fraction (LVEF) 160mmHg and/or diastolic blood pressure >100mmHg despite optimal antihypertensive therapy, and clinically significant as assessed by the investigator). Note: Three 12-lead ECGs showing QTc interval prolongation > 450 milliseconds (ms) (male) must be excluded; Patients with atrial fibrillation or paroxysmal supraventricular tachycardia that need to be treated and whose condition is stable as assessed by the investigator may be considered for inclusion; 10. Serious infection within 4 weeks or active infection within 2 weeks before the first dose; 11. Those who are infected with the following diseases: human immunodeficiency virus (HIV) infection; Subjects with active hepatitis B virus infection [positive hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) test >200 IU/ml or 103 copies/ml]; Hepatitis C virus infected [positive HCV antibody and viral ribonucleic acid (HCV-RNA) test results]; Treponema pallidum antibody positive and RPR positive; 12. Subject's spouse has a pregnancy plan in the past 3 months; 13. Any other disease, medical condition or abnormality, metabolic dysfunction, physical examination findings, clinical laboratory test results contraindicate the use of investigational drugs, may affect the interpretation of results, or may put the subject at high risk for treatment complications, or conditions that are unsuitable for the use of investigational drugs in the judgment of the investigator. Effective contraceptive method and continue contraception for 3 months after the e
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Missed Lesion Detection Rate (Patient-Level); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity grades of adverse events (AEs) and serious adverse events (SAEs); changes from baseline in physical examinations, ECOG performance status scores, laboratory tests, electrocardiograms (ECG), and vital signs.;True Positive Ratio;Positive Predictive Value;Tumor to Background Ratio; | — |
Countries
China
Contacts
Public ContactXu Bin
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University
Outcome results
None listed