The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan It is expected that about 15 people will take part in this research study. Participation in this research study is expected to last about 4 weeks.
This research study is a pilot study, and it is the first time investigators are directly examining the effect of standard androgen receptor antagonists on Prostate-Specific Membrane Antigen (PSMA) expression for participants with recurrent, asymptomatic, metastatic hormone-sensitive prostate cancer (mHSPC). This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy. The research study procedures include screening for eligibility, study imaging and evaluations, blood collections, and follow up visits. The names of the treatment interventions involved in this study are: * Androgen receptor antagonist monotherapy. * PSMA PET/CT scan The U.S. Food and Drug Administration (FDA) has approved apalutamide, darolutamide, and enzalutamide for the treatment of prostate cancer. It is expected that about 15 people will take part in this research study. Participation in this research study is expected to last about 4 weeks. Funding for this research study is provided by a philanthropic gift.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
9
per standard care
Per standard care
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Proportion of Participants with New Lesions (Flare)
Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.
Time frame: week 1
Proportion of Participants with New Lesions (Flare)
Defined as the percentage of patients having the appearance of at least one new suspicious lesion or increase in SUV max relative to each individual's baseline.
Time frame: week 4
Changes in tumor size
Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.
Time frame: week 1
Changes in tumor size
Defined as maximum diameter of lesions for up to 5 target lesions. Standardized Uptake Value Max and Mean.
Time frame: week 4
Changes in tumor SUV
For up to 5 target lesions. Standardized Uptake Value Max and Mean.
Time frame: week 1
Changes in tumor SUV
For up to 5 target lesions. Standardized Uptake Value Max and Mean.
Time frame: week 4
Changes in serum PSA
Time frame: week 1
Changes in serum PSA
Time frame: week 4
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