This phase II trial tests whether 68Gallium PSMA-11 positron emission tomography (PET)/computed tomography (CT) works to detect tumor sites in patients with elevated prostate specific antigen in the blood after initial treatment for prostate cancer (biochemical recurrent) or prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures such as 68Gallium PSMA-11 PET/CT may help in the diagnosis of recurrent or metastatic prostate cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT04483414.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To assess whether gallium Ga 68 gozetotide (68Ga PSMA-11) improves detection of extra-pelvic recurrence of prostate cancer compared to standard of care radiologic imaging in patients with suspected biochemical recurrence (BCR) following either prostatectomy or external beam radiation therapy (EBRT) for primary prostate cancer.
II. To assess PSMA uptake in metastatic lesions in patients with known gross metastatic disease.
SECONDARY OBJECTIVE:
I. To assess whether 68Ga PSMA-11 performance improves detection of possible residual prostate cancer in the pelvis compared to standard of care radiologic imaging and in evaluation of response to treatment in patients with BCR and in patients with known advanced metastatic disease prior to, during and following salvage therapy.
OUTLINE:
Patients receive gallium Ga 68 gozetotide intravenously (IV) and undergo PET/CT over 20-30 minutes. Patients may undergo additional gallium Ga 68 gozetotide PET/CT during treatment and at the end of treatment.
After completion of study intervention, patients are followed up for up to 2 years.
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorNeil Rofsky