Clinical trial NCT06054789: Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Official title: Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate-Specific Membrane Antigen (PSMA)
PET/CT
Prostate cancer
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Tumor detection rate
timeFrame: 2 years
measure: Standardized uptake value (SUV) of tumor
timeFrame: 2 years
Secondary outcomes:
measure: Safety and Tolerability Profile Measured by Adverse Events (AEs)
timeFrame: 2 years
Other outcomes:
Locations:
city: Nanjing
country: China
facility: 68Ga-PSMA-33 PET/CT imaging
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Feng Wang
role: STUDY_DIRECTOR
References: