Prostate cancer
Conditions
Interventions
Dose group 1:0.06 mg/kg intravenous infusion 24 hours preoperatively
Dose group 2:0.03 mg/kg intravenous infusion 24 hours preoperatively
Dose group 3:0.03 mg/kg intravenous infusion 12 hours preoperatively
Dose group 4:0.045 mg/kg intravenous infusion 24 hours preoperatively
Sponsors
The Fourth Affiliated Hospital of Soochow University (Dushu Lake Hospital, Suzhou)
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Patients who meet all the following criteria can be selected for this study: 1. Before the trial, the patient must have informed consent to the trial, fully understand the content, process and possible adverse reactions of the trial, be able to communicate well with researchers and complete the trial according to the scheme, and voluntarily sign a written informed consent form; 2. Adult male patients aged 18 to 80 (inclusive); 3. Preoperative prostate biopsy confirmed by pathologists as a patient with prostate cancer (Gleason score >=7) and planned prostatectomy and/or pelvic lymph node dissection; 4. No liver or kidney damage: liver: total bilirubin =50mL/min(Cockcroft-Gault formula); 5. According to the research doctor's judgment, the patient has no definite contraindications for surgery and is suitable for laparoscopic radical prostatectomy; 6. Patients and their partners or spouses must agree that there is no birth plan, sperm donation and egg donation plan within 3 months from the screening period to the end of the trial, and take effective contraceptive measures voluntarily.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria shall not be enrolled in this study: 1. Allergic constitution (such as those who are known to have allergic history to two or more drugs), or those who are prone to allergic symptoms such as rash and urticaria, or patients who are known to be allergic to test drugs (including their components); 2. The patient is currently suffering from severe lower urinary tract and urethral diseases and/or neurological diseases involving urination function or liver and kidney damage; 3. Patients with non-infectious pneumonia or showing their characteristics; 4, physical examination, laboratory examination, 12-lead electrocardiogram, other imaging examination, the results are obviously abnormal and the researchers think it has clinical significance; 5. There are definite distant metastases (other organ metastases, bone metastases, etc.) at the time of diagnosis, except pelvic lymphadenopathy; 6. Have a clear history of serious neurological or mental disorders in the past, including epilepsy or dementia; 7. Patients with active and severe autoimmune diseases; Acquired, congenital immunodeficiency disease, HIV positive, and a history of organ transplantation; 8. Those who have participated in other drug trials and taken drugs within one month before screening, or those who have participated in medical device trials; Or are participating in other clinical trials; 9. There are patients with accompanying diseases that seriously endanger the safety of patients and affect the completion of the study, or there are other circumstances that are not suitable for participating in the researcher according to the judgment of the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoint evaluation indicators include the number of cases, times and incidence of adverse events/reactions, physical examination, changes in vital signs, electrocardiogram, laboratory test values and other indicators. ;Treatment-Emergent Adverse Events (TEAE);Treatment-Emergent Serious Adverse Events (TESAE);Treatment-Emergent Suspected Unexpected Serious Adverse Reactions (SUSAR);TEAEs leading to treatment discontinuation;;Management of TEAEs;To evaluate the sensitivity (or true positive rate, TP/[TP+FN]) of DGPR1008 in detecting PSMA-expressing or prostate cancer cells via near-infrared imaging;;To evaluate the specificity (or true negative rate, TN/[TN+FP]) of DGPR1008 in detecting PSMA-expressing or prostate cancer cells via near-infrared imaging;;To evaluate the false positive rate (FP/[FP+TN]) of DGPR1008 in detecting PSMA-expressing or prostate cancer cells via near-infrared imaging;;To evaluate the false negative rate (FN/[FN+TP]) of DGPR1008 in detecting PSMA-expressing or prostate cancer cells via near-infrared imaging;;To evaluate the tumor-to-background ratio (TBR).; | — |
Countries
China
Contacts
Public ContactJinxian Pu
The Fourth Affiliated Hospital of Soochow University (Dushu Lake Hospital, Suzhou)
Outcome results
None listed