Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

NCT04573231 | Recruiting Phase 2 DMC FDA Drug

• 5 other identifiers: 2020-0949A539300SMPH/RADIOLOGY/RADIOLOGYProtocol Version 12/12/2025NCI-2020-07434
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Expression of PSMA in CTCs

  up to 2 weeks

• Expression of PSMA in diagnostic metastatic tissue

  up to 3 days

• Change in PSMA Expression on CTCs after 2 weeks of bicalutamide

  baseline and up to 2 weeks

Study Arms (1)

18F-DCFPyL PSMA-based PET/CT

EXPERIMENTAL

* 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

Interventions

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.

18F-DCFPyL PSMA-based PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amy Fowler, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Radiology Studies

CONTACT

608-282-8349; radstudy@uwhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase 2, single-center, open-label study

Study Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: May 24, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)