PSMA Imaging for Breast Cancer

Overseen By Radiology Studies

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Wisconsin, Madison

Disqualifiers: Other malignancy, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 3 days

13 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how a special imaging method can help understand treatment resistance in a type of breast cancer lacking certain common markers but possessing androgen receptors (proteins that bind male hormones). Researchers seek to determine if a marker called PSMA is linked to resistance against bicalutamide, a treatment used in some prostate cancers. The trial includes a PET/CT scan using 18F-DCFPyL (a radiotracer for imaging) and a blood test. Suitable participants have metastatic breast cancer that is HER2-negative and AR-positive (10% or more AR presence). As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that this imaging technique is safe for breast cancer patients?

Research has shown that the 18F-DCFPyL PET/CT scan is generally safe. In past studies, this scan identified cancer cells by targeting a molecule called PSMA, often found in larger amounts on cancer cells.

Patients have tolerated the scans well, with no major safety issues reported. While side effects can occur with any medical procedure, no significant problems have been linked to the use of 18F-DCFPyL in these studies.

These studies also demonstrate that the scan can successfully detect cancer spread to areas like lymph nodes and bones, supporting its safety and effectiveness as a tool for finding cancer.

For those considering participation in a trial using this scan, the safety record is reassuring based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard imaging methods for breast cancer, which typically rely on traditional PET scans or MRIs, 18F-DCFPyL is unique because it targets the prostate-specific membrane antigen (PSMA), a protein that's also found in breast cancer cells. This innovative approach allows for more precise imaging, making it easier to detect and assess the cancer. Researchers are excited about this because it could lead to earlier and more accurate diagnoses, potentially improving treatment outcomes and providing a clearer picture of how the cancer is responding to therapy.

What evidence suggests that this PSMA imaging is effective for breast cancer?

Research shows that a protein called prostate-specific membrane antigen (PSMA) is often used to image prostate cancer and might be useful for other cancers too. In this trial, participants will undergo a special scan called the 18F-DCFPyL PET/CT to see if it can find PSMA in certain breast cancer cells. Previous studies with prostate cancer patients found that this scan changed treatment plans for about 43.5% of them. The scan also proved very accurate, correctly identifying cancer in about 85% of cases according to different medical experts. This suggests that this imaging method might help determine which breast cancer patients could benefit most from specific treatments. ^{1 5 6 7 8}

Who Is on the Research Team?

Steve Y Cho, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 18F-DCFPyL

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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 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 of 93 patients with biochemically recurrent prostate cancer, 18F-DCFPyL PET/CT scans identified disease in 82% of cases, significantly outperforming conventional imaging, which had an accuracy below 20%.

The use of 18F-DCFPyL PET/CT led to a change in management for 44% of patients, often shifting treatment from androgen deprivation therapy to targeted radiotherapy, highlighting its potential to improve patient outcomes.

NCBI (Pubmed)

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. Chaussé, G., Ben-Ezra, N., Stoopler, M., et al.[2021]

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]

The synthesized imaging agent [(18)F]DCFPyL effectively targets the prostate-specific membrane antigen (PSMA), showing a strong binding affinity (K(i) value of 1.1 nmol/L) and high uptake in PSMA-positive prostate tumors in mouse models.

[(18)F]DCFPyL demonstrated significant tumor delineation in PET imaging, with a remarkable uptake ratio of 358:1 between PSMA-positive and PSMA-negative tumors, indicating its potential as a specific imaging tool for prostate cancer with minimal uptake in non-target tissues.

NCBI (Pubmed)

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. Chen, Y., Pullambhatla, M., Foss, CA., et al.[2021]

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

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. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11816243/

Unveiling Prostate-Specific Membrane Antigen's Potential ... This study explores the potential of a protein called prostate-specific membrane antigen (PSMA), which is widely used in prostate cancer (PCa) imaging and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06586047

Study Details | NCT06586047 | Breast Cancer PSMA PET The study will evaluate the expression of PSMA via 18 F-DCFPyL-PET/CT in metastatic TNBC patients and compare it with lesion detection rate of ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.5501

Impact of PSMA-targeted imaging with 18F-DCFPyL-PET ... The study achieved its primary endpoint: CLR of 84.8% to 87.0% among the three PyL-PET/CT readers; the LLCI for CLR by all three reviewers was > ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1355236/full

Effect of 18 F-DCFPyL PET on changes in management ... The pooled proportion of prostate cancer patients experienced management changes was 43.5%, and 18F-DCFPyL PET has a significant impact on treatment options.

5. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-06869

18 F-DCFPyL-PET/CT in Detecting PSMA Expression ... This phase II trial tests how well 18F-DCFPyL positron emission tomography (PET)/computed tomography (CT) scan works in detecting a specific molecule called ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9831858/

PSMA-based 18F-DCFPyL PET: a better choice than ... 18 F-DCFPyL PET/CT has a better diagnostic performance in detecting lymph node metastases and bone metastases for lesion-based analysis.

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.211824

Effect of 18F-DCFPyL PET/CT on the Management ... Effect of 18F-DCFPyL PET/CT on the Management of Patients with Recurrent Prostate Cancer: Results of a Prospective Multicenter Registry Trial | ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9619197/

18F-DCFPyL PET/CT for Initially Diagnosed and ... If lesions were deemed safe for biopsy, then the safest representative lesion was biopsied per protocol within 14 days of DCFPyL PET/CT.