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Evaluating PSMA in HER2-negative, AR-positive Metastatic Breast Cancer

This study is looking at how a protein called PSMA (prostate specific membrane antigen) is expressed in people with metastatic breast cancer that is HER2-negative and AR-positive (meaning it has androgen receptors). Researchers will use a special imaging drug called 18F-DCFPyL to see how much PSMA is present. They believe that high PSMA expression might mean the cancer is resistant to certain anti-androgen treatments, similar to what's seen in prostate cancer. The goal is to find a way to identify patients who would benefit most from these therapies in the future. You may be eligible if you have metastatic HER2-negative breast cancer with at least 10% AR expression. The study aims to enroll 13 people, and success will be measured by how much PSMA is detected using the 18F-DCFPyL imaging.

Study design
This is an interventional study, meaning participants will receive a specific intervention (18F-DCFPyL). It plans to enroll 13 participants.
What's involved
Participants will be on study for about 3 days. PSMA expression will be measured by 18F-DCFPyL SUV (a measure of drug uptake) over up to 3 days.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT04573231

Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
University of Wisconsin, Madison
~13 participants
Updated 2026-08-07 on ClinicalTrials.gov
What's tested:18F-DCFPyL

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
PSMA Expression as measured by 18F-DCFPyL SUV
Measured over up to 3 days

Conditions

Breast Cancer
HER2-negative Breast Cancer
Metastatic Breast Cancer

Explore related trials

Breast CarcinomaAR Gene

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Amy Fowler, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Radiology Studies
[email protected]
608-282-8349
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%

Exclusion

Other (non-breast) known active malignancy. Participants with previously treated cancers which are in remission or have no evidence of disease are eligible.
Unable to lie flat during or tolerate PET/CT
Participants with any medical condition or other circumstances that, in the opinion of the investigator, compromise the safety or compliance of the subject to produce reliable data or completing the study
Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET/CT

What this trial measures

  • PSMA Expression as measured by 18F-DCFPyL SUVup to 3 days

    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.