Recruiting
Phase 2

PSMA

Sponsor:

University of Wisconsin, Madison

Code:

NCT04573231

Conditions

Breast Cancer

HER2-negative Breast Cancer

Metastatic Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

18F-DCFPyL

Study Details

Brief summary:

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.

Conditions

Breast Cancer

HER2-negative Breast Cancer

Metastatic Breast Cancer

Study ID

NCT04573231

Start date

May 24, 2021

Status verified date

Aug, 2026

Completion date

Aug, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

13 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 18F-DCFPyL PSMA-based PET/CT

  • 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

Interventions

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.

Primary outcome measure

  • PSMA Expression as measured by 18F-DCFPyL SUV [ Time Frame: up to 3 days ]

Central Contacts and Locations

Central contacts

Radiology Studies

608-282-8349radstudy@uwhealth.org

Locations

University of Wisconsin School of Medicine and Public Health

Recruiting

Madison, Wisconsin, United States, 53705

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Aug 7, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-08-07.