NCT03803475

Gallium-68 PSMA-11 PET Imaging in Prostate Cancer Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 485 (actual)
• Sponsor: Thomas Hope · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators are imaging patients with prostate cancer using a new Positron Emission Tomography (PET) imaging agent (Ga-68-PSMA-11) in order to evaluate its ability to detect prostate cancer.

Detailed description

Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol. PET imaging will begin 50-100 minutes after injection, but may be possible in certain circumstances for imaging to be delayed due to patient workflow or equipment issues Primary Objective: Sensitivity on a per-patient and per-region-basis (Table 1) of 68Ga-PSMA-11 PET for detection of tumor location confirmed by histopathology/biopsy, clinical and conventional imaging follow-up.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Ga-68 labeled PSMA-11	Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
DEVICE	Positron emission tomography-computed tomography (PET/CT)	Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session
DEVICE	Positron emission tomography-magnetic resonance imaging (PET/MRI)	A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session

Timeline

• Start date: 2018-10-11
• Primary completion: 2020-08-25
• Completion: 2020-08-25
• First posted: 2019-01-14
• Last updated: 2021-08-24
• Results posted: 2021-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study