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Evaluation of [Ga-68]PSMA Digital PET/CT for the Detection of Bone Metastases in Patients with Prostate Cancer

Trial Status: active

This clinical trial evaluates a radioactive diagnostic study drug, which is called gallium-68 (Ga-68) prostate specific membrane antigen (PSMA) for detection of prostate cancer that has spread from where it first started (primary site) to the bone (metastatic). Prostate cancer is the second most common cancer in men worldwide and one of the leading causes of morbidity and death in the Western world. Most frequent sites of metastases from prostate cancer are lymph nodes and bone and 90% of patients who die of prostate cancer harbor bone metastases. Early detection or exclusion of bone metastases is of high clinical importance in management of patients with high-risk prostate cancer. Positron emission tomography (PET) scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. Because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. Computed tomography (CT) scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create three-dimensional (3-D) views of tissues and organs. Flourine-18 (F-18) sodium fluoride (NaF) is a radiotracer that is absorbed directly onto the surface of the bone matrix and is the standard imaging agent for evaluating the presence of bone metastases. [Ga-68]PSMA is an investigational agent that works by binding to prostate specific membrane antigen, which is overexpressed in prostate cancer. It has shown to be an effective imaging agent for diagnosing and staging prostate cancer, but little is known about its ability to detect bone lesions. Information gained from this study may allow researchers to determine whether new diagnostic procedures, such as digital PET/CT using [Ga-68]PSMA, will help detect bone metastases in patients with prostate cancer and find out how far the disease has spread compared to standard of care imaging with [F-18]NaF.