Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer

Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer

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).

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.

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