PSMA Imaging for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Steve Y Cho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Wisconsin, Madison

Disqualifiers: Other malignancy, Pregnancy, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team to get a clear answer.

What data supports the effectiveness of the treatment 18F-DCFPyL PET/CT for breast cancer?

Research shows that 18F-DCFPyL PET/CT is effective in detecting prostate cancer lesions better than conventional imaging methods. However, its effectiveness in breast cancer is not directly supported by the available data. ^{1 2 3 4 5}

Is PSMA Imaging with 18F-DCFPyL safe for humans?

The safety of 18F-DCFPyL, a PSMA-targeted imaging agent, has been initially evaluated in patients with prostate cancer, showing it to be generally safe for human use. ^{1 3 4 6 7}

How does PSMA Imaging for Breast Cancer differ from other treatments?

PSMA Imaging for Breast Cancer is unique because it uses a radiotracer that targets the prostate-specific membrane antigen (PSMA), which is typically used in prostate cancer imaging. This approach is novel for breast cancer, as it leverages a method primarily used for another type of cancer, potentially offering new insights into breast cancer detection and management. ^{5 7 8 9 10}

Research Team

Steve Y Cho, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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.

Inclusion Criteria

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

Exclusion Criteria

I have a history of cancer but am currently in remission or have no signs of disease.

I cannot lie flat for scans.

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

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants undergo 18F-DCFPyL PSMA-based PET/CT scan and related assessments

3 days

1 visit (in-person)

Follow-up

Participants are monitored for changes in PSMA expression on CTCs and diagnostic tissue

2 weeks

Treatment Details

Interventions

• 18F-DCFPyL (Imaging Agent)

Trial Overview 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.

Participant Groups

Group I: 18F-DCFPyL PSMA-based PET/CT Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Robert Drape

University of Wisconsin, Madison

Chief Executive Officer since 2007

Executive MBA from the University of Wisconsin – Madison, Bachelor's degree in Biology from Augustana College (IL)

Dr. Ciara Barclay-Buchanan

University of Wisconsin, Madison

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Findings from Research

The use of PSMA-targeted 18F-DCFPyL PET/CT in three patients with metastatic urothelial carcinoma showed that while it could detect cancer sites, the radiotracer uptake was low, indicating limited effectiveness for this type of cancer.

RNA-sequencing and immunohistochemical analysis revealed that urothelial carcinoma has significantly lower PSMA expression compared to prostate cancer and clear cell renal cell carcinoma, suggesting that PSMA-targeted imaging may not be a viable option for detecting urothelial carcinoma and highlighting the need for alternative imaging strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low levels of PSMA expression limit the utility of 18F-DCFPyL PET/CT for imaging urothelial carcinoma. Campbell, SP., Baras, AS., Ball, MW., et al.[2023]

The study found that [18F]DCFPyL PET/CT imaging successfully detected primary tumors in 7 out of 10 patients with colorectal, gastric, and pancreatic cancers, indicating its potential as a diagnostic tool.

However, the imaging was less effective than the standard [18F]FDG PET/CT due to low tumor expression and high background uptake, which made it difficult to clearly distinguish tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate-Specific Membrane Antigen Targeted Pet/CT Imaging in Patients with Colon, Gastric and Pancreatic Cancer. Vuijk, FA., Kleiburg, F., Noortman, WA., et al.[2022]

The study of [(18)F]DCFPyL in nine prostate cancer patients showed that it is safe, with no major adverse events related to the radiotracer observed during the imaging process.

[(18)F]DCFPyL demonstrated high accumulation in prostate cancer sites, indicating effective targeting for imaging, and its radiation dose is comparable to other PET radiotracers, making it a viable option for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. Szabo, Z., Mena, E., Rowe, SP., et al.[2022]

The small molecule PSMA inhibitor [18F]DCFPyL has shown promising results as a radiotracer for imaging prostate cancer and other tumors expressing PSMA, indicating its potential clinical utility.

This review highlights various radiosynthetic methods for producing [18F]DCFPyL and summarizes preclinical and clinical data supporting its effectiveness in detecting prostate cancer and clear cell renal cell carcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of Prostate-Specific Membrane Antigen Using [18F]DCFPyL. Rowe, SP., Gorin, MA., Pomper, MG.[2022]

The study evaluated the dosimetry of the PET radiotracer 18F-DCFPyL in nine patients with metastatic prostate cancer, revealing that the lacrimal glands received the highest absorbed dose, which is important for understanding potential side effects during imaging and therapy.

Using advanced Monte-Carlo models, the research provided new insights into the dose received by the lacrimal and salivary glands, which are critical for assessing the safety and efficacy of 18F-DCFPyL in clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. Plyku, D., Mena, E., Rowe, SP., et al.[2018]

In a study involving 14 patients with biochemically relapsed prostate cancer, the new fluorine-18 labeled tracer [(18)F]DCFPyL was found to detect all lesions identified by the traditional gallium-68 labeled tracer [(68)Ga]Ga-PSMA-HBED-CC, and additionally revealed extra lesions in three patients.

[(18)F]DCFPyL demonstrated significantly higher image quality, with greater maximum standardized uptake values (SUVmax) and better tumor-to-background ratios compared to [(68)Ga]Ga-PSMA-HBED-CC, suggesting it could be a superior option for PSMA-PET/CT imaging in detecting prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. Dietlein, M., Kobe, C., Kuhnert, G., et al.[2021]

In a study of 56 patients with suspected prostate cancer, the novel radiotracer 18F-DCFPyL demonstrated high sensitivity (90%) and specificity (100%) for detecting prostate cancer, making it a reliable diagnostic tool.

The imaging results showed a strong correlation between the radiotracer uptake (measured by SUVmax and SULmax) and serum PSA levels, indicating that 18F-DCFPyL PET/CT is effective for initial diagnosis and lymph node staging in suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. Zhang, T., Yang, S., Lin, L., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]

2. Japan pubmed.ncbi.nlm.nih.gov

Low levels of PSMA expression limit the utility of 18F-DCFPyL PET/CT for imaging urothelial carcinoma. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Prostate-Specific Membrane Antigen Targeted Pet/CT Imaging in Patients with Colon, Gastric and Pancreatic Cancer. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Initial Evaluation of [(18)F]DCFPyL for Prostate-Specific Membrane Antigen (PSMA)-Targeted PET Imaging of Prostate Cancer. [2022]

5. Canada pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 18F-DCFPyL positron emission tomography/computed tomography for biochemically recurrent prostate cancer and change-of-management analysis. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Imaging of Prostate-Specific Membrane Antigen Using [18F]DCFPyL. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

2-(3-{1-Carboxy-5-[(6-[18F]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic acid, [18F]DCFPyL, a PSMA-based PET imaging agent for prostate cancer. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Combined model-based and patient-specific dosimetry for 18F-DCFPyL, a PSMA-targeted PET agent. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Comparison of [(18)F]DCFPyL and [ (68)Ga]Ga-PSMA-HBED-CC for PSMA-PET Imaging in Patients with Relapsed Prostate Cancer. [2021]

10. Greece pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]