A Phase 2 interventional study of 18F-DCFPyL in Breast Cancer, HER2-negative Breast Cancer and Metastatic Breast Cancer, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by University of Wisconsin, Madison · Phase 2, Interventional, and Diagnostic
The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide. The investigators hypothesize that PSMA expression will correlate with resistance to anti-androgen therapies, as has been documented in prostate cancer, and this can be used to select patients most likely to benefit from these therapies in future clinical trials. 15 people with HER2-negative, AR-positive metastatic breast cancer will be enrolled and be on study for about 3 days.
Primary Objective:
Secondary Objectives:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 13 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
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Exclusion Criteria:
* 18F-DCFPyL whole body PET/CT scan * Review of relevant imaging and medical record information * Blood draw for circulating tumor cells (CTCs) * Analysis of diagnostic tissue specimens
Drug: 18F-DCFPyL
PSMA is highly expressed on prostate cancer and is associated with metastasis and resistance to anti-androgen therapies. Researchers have evaluated the expression of PSMA in the tumor and tumor-associated neovasculature in primary tumors and distant metastases in patients with breast cancer.
PSMA Expression as measured by 18F-DCFPyL SUV
Quantitative analysis of 18F-DCFPyL PSMA PET uptake will be performed at the lesion-level. Standardized uptake values (SUV) will be measured by manually drawing a region of interest (ROI) to encompass the entire lesion guided by the lesion extent visualized on conventional imaging. PET SUV based quantitative tumor uptake parameters will be obtained.
Time frame: up to 3 days
Expression of PSMA in CTCs
Expression of PSMA in CTCs will be measured via immunofluorescence.
Time frame: up to 2 weeks
Expression of PSMA in diagnostic metastatic tissue
PSMA expression in tumors will be semi-quantitatively scored by a study pathologist using published methods including separate assessment of tumor-associated and non-tumor vasculature, with the endothelium highlighted by a CD31 immunostain to facilitate definitive recognition.
Time frame: up to 3 days
Change in PSMA Expression on CTCs after 2 weeks of bicalutamide
The change in PSMA expression on CTCs will be measured pre and post treatment via immunofluorescence.
Time frame: baseline and up to 2 weeks
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison