NCT04216134

68Ga-PSMA-11 PET for the Diagnosis of Biochemically Recurrent Prostate Cancer

A Phase I Study of 68GA-PSMA-11 PET Imaging for Biochemically Recurrent Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial studies the side effects of 68GA-PSMA-11 PET imaging in patients with prostate cancer that has come back (recurrent). Gallium (68Ga) is a radiotracer that binds to a molecule, PSMA, that is found in abundance on most prostate cancer cells. PSMA is short for 'prostate specific membrane antigen'. Diagnostic procedures, such as 68GA-PSMA-11 PET imaging, may help measure a patient's response to earlier treatment, and may help plan the best treatment for prostate cancer.

Detailed description

PRIMARY OBJECTIVE: I. To provide clinical access to and assess the safety of the investigational agent Gallium Ga 68-labeled prostate specific membrane antigen (PSMA)-11 (68Ga-PSMA-11) positron emission tomography (PET) at City of Hope National Medical Center for patients co-enrolled on Institutional Review Board (IRB) 18517 treatment trial. OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 intravenously (IV) over less than 1 minute, and then undergo PET over 60 minutes. After completion of study, patients are followed up at 1-3 days, and then at 3 weeks.

Conditions

• Biochemically Recurrent Prostate Carcinoma

Interventions

Type	Name	Description
DRUG	Gallium Ga 68-labeled PSMA-11	Given IV
PROCEDURE	Positron Emission Tomography	Undergo 68GA-PSMA-11 PET

Timeline

• Start date: 2019-12-12
• Primary completion: 2022-12-09
• Completion: 2022-12-09
• First posted: 2020-01-02
• Last updated: 2023-06-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study