This trial studies the effect of androgen receptor signaling inhibitors on 68Ga-PSMA-11 PET/CT imaging in patients with castration-resistant prostate cancer that has spread to other places in the body (metastatic). Diagnostic procedures, such as 68Ga-PSMA-11 PET/CT, may help in learning how well androgen receptor signaling inhibitors work in killing castration-resistant prostate cancer cells and allow doctors to plan better treatment.
PRIMARY OBJECTIVE: I. To evaluate short- and long-term prostate specific membrane antigen (PSMA) imaging changes in response to androgen receptor signaling inhibitors (ARSI). SECONDARY OBJECTIVES: I. To correlate PSMA imaging changes with prostate specific antigen (PSA) kinetics. II. To correlate PSMA imaging changes with progression free survival. III. To evaluate the changes in PSMA PET staging (miTNM Prostate Cancer Molecular Imaging Standardized Evaluation \[PROMISE\] criteria) under ARSI. OUTLINE: Patients receive gallium Ga 68-labeled PSMA-11 (68Ga-PSMA-11) intravenously (IV). After 50-100 minutes, patients undergo positron emission tomography (PET)/computed tomography (CT) over 20-50 minutes. Patients undergo 68Ga-PSMA-11 PET/CT at baseline, at 1 week and 3 months after initiation of ARSI, and at time of biochemical progression (within 1 year if applicable).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
9
Undergo 68Ga-PSMA-11 PET/CT
Given IV
Undergo 68Ga-PSMA-11 PET/CT
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Changes in 68Ga-PSMA-11 lesion and total-body uptake (standardized uptake value [SUV]max and SUVmean) over time in response to androgen receptor signaling inhibitors (ARSI)
Changes are expressed in terms of percentage changes from baseline positron emission tomography (PET) (before ARSI). Will utilize mixed effect regression models to evaluate the change over time in PSMA results.
Time frame: Baseline, assessed up to 1 year
Prostate specific antigen (PSA) kinetics under ARSI
Comparison of 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes over time to PSA kinetics under ARSI. Will use mixed effects regression models to correlate the PSMA and PSA time trends. These models will include the effect of time and the PSMA by time interaction effect.
Time frame: Baseline, assessed up to 1 year
Biochemical progression free survival (bPFS)
Correlation between 68Ga-PSMA-11 uptake (SUVmax and SUVmean) changes and time of bPFS under ARSI. Will utilize Cox-proportional hazards regression models. PSMA results will be treated as a time dependent covariate in these models.
Time frame: Up to 1 year
Changes in lesion size on cross sectional imaging under ARSI
Correlation between SUVmax from 68Ga-PSMA-11 PET and lesion size on cross sectional imaging under ARSI.
Time frame: Up to 1 year
Changes in staging (PSMA miTNM PROMISE criteria) under ARSI
Will utilize mixed effects regression models to evaluate the change in staging over time.
Time frame: Up to 1 year
Incidence of adverse events
Assessed by Common Terminology Criteria for Adverse Events 4.03.
Time frame: Up to 1 year
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