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

NCT06054789 | Unknown

• 1 other identifier: 68Ga-PSMA-33
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Prostate Cancer

Keywords

Prostate-Specific Membrane Antigen (PSMA); PET/CT; Prostate cancer

Outcome Measures

Primary Outcomes (2)

• Tumor detection rate

  Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.

  2 years

• Standardized uptake value (SUV) of tumor

  Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.

  2 years

Secondary Outcomes (1)

• Safety and Tolerability Profile Measured by Adverse Events (AEs)

  2 years

Study Arms (1)

68Ga-PSMA-33

EXPERIMENTAL

For the injection, subjects will receive a target dose of 3-7mCi 68Ga-PSMA-33 as a bolus injection. Among them, 3\~4 subjects will additionally inject with 68Ga-PSMA-617 (3-7mCi).

Drug: 68Ga-PSMA-33

Interventions

68Ga-PSMA-33 DRUG

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.

Also known as: 68Ga-PSMA-617

68Ga-PSMA-33

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

68Ga-PSMA-33 PET/CT imaging

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Feng Wang

  Nanjing First Hospital, Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang

CONTACT

02552271276; fengwangcn@hotmail.com

Wenyu Wu

CONTACT

02552271276; 15150513147@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 26, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: September 26, 2023

Record last verified: 2023-09

Locations

CN (1)