Prostate Cancer Clinical Trial
68Ga-PSMA-11 PET/CT for the Diagnosis of Bone Metastases in Patients With Prostate Cancer and Biochemical Progression During Androgen Deprivation Therapy
This phase II trial studies how well 68Ga-PSMA-11 positron emission tomography (PET)/computed tomography (CT) works in detecting the spread of cancer to the bones (bone metastasis) in patients with prostate cancer and increased PSA after treatment (biochemical recurrence) during androgen deprivation therapy. Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help find and diagnose prostate cancer and find out how far the disease has spread.
I. To compare the per-patient detection rate of 68Ga-PSMA-11 PET/CT versus bone scan (BS)/CT for M1b in patients treated with androgen deprivation therapy (ADT) who are referred for the imaging evaluation of disease progression.
I. To compare the number of lesions rated as positive for bone metastases between the two imaging tests.
II. To compare the detection rate of 68Ga-PSMA PET/CT versus BS/CT for all M1 disease (M1a or M1b or M1c).
III. To compare the positive predictive value (PPV) per-patient in patients with lesion validation (follow-up imaging or biopsy).
Patients receive gallium Ga 68 gozetotide intravenously (IV). After 50-100 minutes, patients undergo whole body PET/CT.
Patient with biochemical progression during ADT or combination therapies including ADT who are referred for imaging evaluation (prostate specific antigen [PSA] level >= 1 ng/ml that has increased on at least 2 successive occasions at least 1 weak apart)
Patients with bone scan scheduled or performed
Within 30 days of the PSMA PET, without any new prostate cancer (PCa) therapy in between
Bone scans performed at University of California, Los Angeles (UCLA) and external institutions are eligible if Digital Imaging and Communications in Medicine (DICOM) images can be obtained, imported, and anonymized
Patients enrolled in other clinical trials are eligible if they satisfy all other criteria of eligibility
Patients or their legal representatives must have the ability to read, understand and provide written informed consent
Initiation of a new therapy between the PSMA PET/CT and the bone scans
Inability to provide written informed consent
Known inability to remain still and lie flat for duration of each imaging procedure (about 30 minutes)
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There is 1 Location for this study
Los Angeles California, 90095, United States
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