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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

Must not have

Unable to lie flat during or tolerate PET/CT

Women of childbearing potential must not be pregnant or breast feeding (pregnancy test negative within 7 days prior to PET/CT)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a new imaging substance in scans to study specific markers in patients with a certain type of breast cancer. It aims to understand why some treatments don't work well for these patients.

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.

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.

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

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My breast cancer is metastatic, HER2-negative with AR expression ≥ 10%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot lie flat for scans.

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I am not pregnant or breastfeeding, confirmed by a recent test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PSMA Expression as measured by 18F-DCFPyL SUV

Secondary study objectives

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

Headache

Hypertension

Fatigue

100%

80%

60%

40%

20%

Study treatment Arm

18F-DCFPyL Injection

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~600

0 / 3Eligibility criteria met