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| ID | Type | Description | Link |
|---|---|---|---|
| A539300 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY/RADIOLOGY | Other Identifier | UW Madison | |
| Protocol Version 12/12/2025 | Other Identifier | UW Madison | |
| NCI-2020-07434 | Registry Identifier | NCI CTRP | |
| 2020-0949 | Other Identifier | UW Madison |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-DCFPyL PSMA-based PET/CT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-DCFPyL | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Expression of PSMA in CTCs | Expression of PSMA in CTCs will be measured via immunofluorescence. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Radiology Studies | Contact | 608-282-8349 | radstudy@uwhealth.org |
| Name | Affiliation | Role |
|---|---|---|
| Amy Fowler, MD, PhD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin School of Medicine and Public Health | Recruiting | Madison | Wisconsin | 53705 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C572626 | 2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid |
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Phase 2, single-center, open-label study
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| 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. | baseline and up to 2 weeks |
| D017437 |
| Skin and Connective Tissue Diseases |