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PSMA Imaging for Breast Cancer

Phase 2
Recruiting
Led By Steve Y Cho, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients diagnosed with metastatic HER2-negative breast cancer AR expression of ≥ 10%
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 days
Awards & highlights

Study Summary

This trial is testing a way to predict if a certain breast cancer will respond to a common treatment, by looking at a protein called PSMA.

Who is the study for?
This trial is for people with a specific type of advanced breast cancer that doesn't respond to usual hormone therapies (HER2-negative, AR-positive). They must have at least 10% AR expression in their tumors. It's not for those with other active cancers, who can't lie flat for scans, or women who could be pregnant or are breastfeeding.Check my eligibility
What is being tested?
The study is testing the presence of PSMA in certain breast cancers and its link to resistance against anti-androgen therapy like bicalutamide. Researchers think PSMA might help identify which patients would benefit from these treatments. Participants will undergo PET/CT scans using a tracer called 18F-DCFPyL.See study design
What are the potential side effects?
While the document does not specify side effects related to the intervention (18F-DCFPyL), typical PET/CT scan tracers may cause mild reactions such as nausea or a feeling of warmth. Serious allergic reactions are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My breast cancer is metastatic, HER2-negative with AR expression ≥ 10%.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PSMA Expression as measured by 18F-DCFPyL SUV
Secondary outcome measures
Change in PSMA Expression on CTCs after 2 weeks of bicalutamide
Expression of PSMA in CTCs
Expression of PSMA in diagnostic metastatic tissue

Side effects data

From 2019 Phase 3 trial • 208 Patients • NCT03739684
1%
Headache
1%
Fatigue
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-DCFPyL Injection

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DCFPyL PSMA-based PET/CTExperimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL
2019
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,531 Total Patients Enrolled
35 Trials studying Breast Cancer
38,504 Patients Enrolled for Breast Cancer
Steve Y Cho, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
104 Total Patients Enrolled

Media Library

18F-DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT04573231 — Phase 2
Breast Cancer Clinical Trial 2023: 18F-DCFPyL Highlights & Side Effects. Trial Name: NCT04573231 — Phase 2
18F-DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT04573231 — Phase 2
Breast Cancer Research Study Groups: 18F-DCFPyL PSMA-based PET/CT

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other ongoing or previous research studies that have used 18F-DCFPyL?

"There are a total of 19 ongoing clinical trials involving 18F-DCFPyL. 0 of those live trials are in Phase 3, with the majority based in Baltimore, Maryland; however, 28 locations across the world are running these types of tests."

Answered by AI

Are there adverse effects to 18F-DCFPyL?

"18F-DCFPyL's safety is estimated to be a 2. This is because, while there is evidence that the medication is safe, its efficacy has yet to be proven in clinical trials."

Answered by AI

What is the number of people being asked to participate in this drug test?

"That is accurate. The listing on clinicaltrials.gov says that the trial is ongoing and looking for 15 more participants. This research was first posted on May 24th, 2021 and was last updated October 18th, 2022."

Answered by AI

Can patients sign up for this trial right now?

"Yes. The information available on clinicaltrials.gov indicates that this study is actively recruiting patients. This particular trial was posted on May 24th, 2021 and was last updated October 18th, 2022. They are searching for a total of 15 patients from 1 location."

Answered by AI

To what conditions does 18F-DCFPyL lend itself as a treatment?

"A common treatment for increased serum prostate specific antigen is 18F-DCFPyL. This medication can also be used to treat conditions such as suspected metastasis, positron emission tomography, and recurrent prostate cancer."

Answered by AI

Who else is applying?

What state do they live in?
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
2021. "Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04573231.
~5 spots leftby Nov 2025
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