Digital PET/CT Using [Ga-68]PSMA for Characterization of Prostate Lesions

Norbert Avril, M.D.

Status and phase: Completed; Phase 3

Conditions: Prostate Cancer

Treatments: Drug: [Ga-68]PSMA; Device: PET/CT imaging

Study type: Observational

Funder types: Other

Identifiers

NCT04867603

CASE1821

Details and patient eligibility

About

The purpose of this study is to evaluate a radioactive diagnostic study drug, which is called Gallium-68 Prostate Specific Membrane Antigen ([Ga-68]PSMA) for characterization of prostate abnormalities.

Full description

Individuals with clinical suspicion of prostate cancer and without prior prostate biopsy are offered abbreviated bi-parametric prostate MRI. As Standard of Care (SOC), MRIs will be examined and scored for likelihood for malignancy using the PI-RADS version 2.1 criteria. Those with PI-RADS 3, 4 or 5 lesions or those with PI-RADS 1 or 2 lesions with clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) will be included on study. Only those receiving care at University Hospitals Cleveland Medical Center will be included into the study.

This study is to evaluate ([Ga-68]PSMA) for characterization of prostate abnormalities. For imaging, an FDA approved imaging technology, digital Positron Emission Tomography (PET/CT) will be used. The study team would like to know if digital PET/CT using [Ga-68]PSMA provides accurate information whether or not a participant has prostate cancer and if there is potential spread of the disease within the body. [Ga-68]PSMA is an investigational (experimental) drug that works by binding to Prostate Specific Membrane Antigen (PSA), which is overexpressed in prostate cancer. [Ga-68]PSMA is experimental because it is not approved by the Food and Drug Administration (FDA). However, FDA approval has been obtained for this study protocol by an Investigational New Drug (IND) application.

Enrollment: 16 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have a clinical suspicion of prostate cancer defined by PI-RADS 3, 4 or 5 lesions detected on MRI as well as patients with negative prostate MRI or those with PI-RADS 1 or 2 lesions if they have continued suspicion for prostate cancer. Patients who cannot undergo MRI imaging but have a clinical suspicion for prostate cancer based on serum PSA level, family history or clinical examination (positive digital rectal examination) can also be included.
• Able to tolerate PET/CT scans
• Informed consent must be given and signed

Exclusion criteria

• Anti-cancer treatment (chemotherapy and/or radiation therapy) within the last 2 weeks
• Known allergy against Ga-68 PSMA
• Prior prostate biopsy within the last 2 weeks

Trial design

16 participants in 1 patient group

Digital PET/CT using [Ga-68]PSMA

Description:

Following prostate Standard of Care MRI, eligible participants will receive a single injection of \[Ga-68\]PSMA followed by digital PET/CT imaging approximately 60 minutes later. PET/CT takes approximately 30-35 minutes, where the participant would lay still on a scanner table.

Treatment:

Drug: [Ga-68]PSMA

Device: PET/CT imaging