Overview

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

Status:
Recruiting
Trial end date:
2024-10-01
Target enrollment:
0
Participant gender:
Male
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).
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Treatments:
Gallium 68 PSMA-11
Criteria
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