Prostate Cancer
Conditions
Keywords
Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer
Brief summary
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).
Detailed description
This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies. The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.
Interventions
DRUG68Ga-PSMA-33
Subjects will receive one injection of 68Ga-PSMA-33/PSMA-617 (3-7mCi ), a PET radiopharmaceutical selective for Prostate-Specific Membrane Antigen. 68Ga-PSMA-33/PSMA-617 injection will be followed by a 10 ml saline flush.
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Male sex * Age 18 years or older * Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer * Creatinine less than or equal to 1.5 X upper limit of normal * ECOG performance status 0 - 2, inclusive * Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation Patient with complete clinical data. * The effects of 68Ga-PSMA-33 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. * Able to understand and provide written informed consent
Exclusion criteria
* Patient age \< 18 years * Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives * Malignancy other than current disease under study * Patient simultaneously participating in another clinical trial * Patient who cannot stay on PET/CT * Patient with HIV, HCV, HVB infection or other serious chronic infection * Patient with liver and kidney function (GFR less than 50 ml/min) disease * Cannot receive furosemide, allergy to sulfa or sulfa-containing medications * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor detection rate | 2 years | Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT. |
| Standardized uptake value (SUV) of tumor | 2 years | Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability Profile Measured by Adverse Events (AEs) | 2 years | Safety and tolerability profile for the administration of 68Ga-PSMA-33 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs). |
Countries
China
Contacts
Primary ContactFeng Wang
Backup ContactWenyu Wu
Outcome results
None listed