Prostate Specific Membrane Antigen Positive Metastatic Prostate Cancer
Conditions
Keywords
PSMA positive metastatic prostate cancer
Brief summary
This study is to evaluate the safety, biodistribution, radiation dosimetry and tumor uptake of the \[131I\]/\[18F\]/\[68Ga\]ZT-111 in patients with PSMA positive metastatic prostate cancer.
Interventions
RADIATION[131I]/[18F]/[68Ga]ZT-111
\[131I\]/\[18F\]/\[68Ga\]ZT-111, single dose
Sponsors
Huashan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 65 years old. 2. Histologically or cytologically confirmed prostate adenocarcinoma with documented history of ≥1 metastatic lesions indicated by imaging. 3. Informed consent must be obtained in writing from the subject, their legally authorized representative, or caregiver. 4. Willing and able to comply with all aspects of this study.
Exclusion criteria
1. Severe hepatic or renal impairment. 2. History of major surgery within the last month. 3. Participation in another concurrent clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry | About 24hours from time of injection | Whole body and organ uptake activity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events | From administration of [131I]/[18F]/[68Ga]ZT-111 until 1 week after injection | Incidence and severity of adverse events (AEs) as assessed by CTCAE v5.0 |
Countries
China
Contacts
Primary ContactYihui Guan, MD
Outcome results
None listed