This is a phase II clinical trial study to show how well the 68Ga-PSMA-11 (ProstaMedix™) PET-CT scan works in detecting tumor location and size in patients with suspected or confirmed prostate cancer, as well as prostate cancer that may have come back in patients with elevated PSA ( a prostate-specific antigen tumor marker) after initial treatment.
68Ga-PSMA-11 is a radioactive imaging contrast agent for use in PET CT scan that seeks to identify prostate cancer cells that have a specific protein target called prostate-specific membrane antigen (PSMA) on their surface. PET and CT make computerizing pictures of areas inside the body where the radioactive substance is lighting up. 68Ga-PSMA-11 PET / CT may be able to see smaller tumors than standard imaging and may help determine whether prostate cancer has come back and where it is in the body. A 68Ga-PSMA-11 PET / CT scan may help doctors to better detect the location, extent, and characteristics of the tumor, allowing improved planning of subsequent therapy
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
208
Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
Radio- Isotope Therapy of America
Houston, Texas, United States
RECRUITINGThe sensitivity of 68Ga-PSMA-11 PET for detection of tumor location.
The sensitivity of 68Ga-PSMA-11 PET to detect tumor location and metastases in patients with biopsy confirmed diagnosis.tumor location confirmed by histopathology/biopsy and conventional imaging follow-up.
Time frame: 12 months
Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value
Detection rates of 68Ga-PSMA-11 PET in patients with different PSA value (0.2 - \<0.5, 0.5 - \<1.0, 1.0 - \<2.0, 2.0 - \<5.0, 5.0).
Time frame: 12 months
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