Prostate Cancer
Conditions
Brief summary
The study is being conducted to evaluate the the safety, pharmacokinetics, radiation dosimetry of HRS-9815 for PET/CT imaging in adult patients with prostate cancer.
Interventions
DRUGHRS-9815 injection
HRS-9815 injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation in this clinical trial, understanding of the study procedures and being able to sign the informed consent form in writing; 2. Male, age ≥18 years; 3. ECOG score 0 - 1; 4. Histologically confirmed adenocarcinoma of the prostate;
Exclusion criteria
1. Severe urinary incontinence, hydronephrosis, severe micturition dysfunction, etc. Note: Subjects with bladder outflow obstruction or urinary incontinence that can be controlled by the best available standard of care (including pads, drainage, etc.) are eligible to participate in the study. 2. Active syphilis infection. 3. Known allergy, hypersensitivity, or contraindication to the trial product or any component of its formulation.。 4. Active in other clinical studies or less than 4 weeks after the last dose in the previous clinical study at the time of the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of AEs and SAEs, | up to 30 days follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Absorbed dose and effective dose of radioactive internal irradiation of the whole body and major organs; | up to 1 days follow-up |
| Mean standardized uptake value (SUVmean) | up to 1 days follow-up |
| Maximum standardized uptake value (SUVmax), | up to 1 days follow-up |
| cumulative urinary excretion rate based on radioactivity; | up to 1 days follow-up |
| Maximum plasma concentration (Cmax) | up to 1 days follow-up |
| time to maximum plasma concentration (Tmax) | up to 1 days follow-up |
| biological half-life (t1/2) | up to 1 days follow-up |
| Tumor-to-background ratio (TBR) [Time Frame: up to 1 days follow-up] | up to 1 days follow-up |
Contacts
Primary ContactXueying Xueying
Outcome results
None listed