PYLARIFY PET-CT Imaging for Cancer

Overseen By Yang Lu, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Chemotherapy, Immunotherapy, Radiotherapy, others

Disqualifiers: Pregnancy, Allergic reactions, Psychiatric illness, others

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

Compensation: Varies

Number of Visits: 1

36 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had chemotherapy, immunotherapy, or radiotherapy within 4 weeks before the trial, you may not be eligible to participate.

What data supports the effectiveness of the drug Piflufolastat F18 in cancer treatment?

Piflufolastat F18 is effective in imaging prostate cancer by targeting a specific protein found in most prostate cancers, helping doctors better understand the spread and stage of the disease. It has been shown to be more effective than standard imaging methods for detecting prostate cancer and its recurrence. ^{1 2 3 4 5}

Is Piflufolastat F18 (PYLARIFY) safe for use in humans?

Piflufolastat F18 (PYLARIFY) is a diagnostic imaging agent approved by the FDA for use in prostate cancer imaging, indicating it has been evaluated for safety in humans. It is used in PET scans to help detect prostate cancer, and its approval suggests it is generally considered safe for this purpose. ^{1 2 3 4 6}

How is the drug PYLARIFY PET-CT Imaging for Cancer different from other treatments?

PYLARIFY, or piflufolastat F 18, is unique because it is a PET imaging agent specifically targeting prostate-specific membrane antigen (PSMA) for better detection and staging of prostate cancer, offering improved sensitivity over conventional imaging methods like CT scans and bone scans. ^{1 2 3 7 8}

What is the purpose of this trial?

To learn if piflufolastat F18 can be used in imaging scans for patients with breast cancer, HCC, or pancreatic cancer

Research Team

Yang Lu, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

Adults with confirmed pancreatic ductal adenocarcinoma, hepatocellular carcinoma (HCC), or invasive lobular breast cancer who may have metastatic disease. Participants must be able to consent, have a measurable lesion, and an estimated life expectancy of at least 3 months. Pregnant women, those allergic to PSMA PET radiopharmaceuticals, or unable to undergo PET-CT are excluded.

Inclusion Criteria

My cancer may have spread, or there's a chance it has spread more than we thought.

I have not started treatment or my current treatment isn't working well, and I am scheduled for a biopsy.

You must have at least one spot that can be accurately measured to see if the treatment is working.

Exclusion Criteria

You have had allergic reactions to PSMA PET radiopharmaceuticals in the past.

I haven't had chemotherapy, immunotherapy, or radiotherapy in the last 4 weeks.

Pregnant or breastfeeding women.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive PYLARIFY (piflufolastat F18) PET-CT scans to assess diagnosis accuracy for detecting metastasis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• Piflufolastat F18

Trial Overview The study is testing the effectiveness of piflufolastat F18 in detecting metastasis through imaging scans in patients with breast cancer, HCC, or pancreatic cancer. It aims to see if this can help assess tumor burden and influence treatment decisions.

Participant Groups

Group I: Piflufolastat F18 Experimental Treatment 1 Intervention

Piflufolastat F18 will first be given by vein over about 5 seconds.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+

Findings from Research

Piflufolastat F 18 (PYLARIFY®) is a newly approved diagnostic imaging agent that targets prostate-specific membrane antigen (PSMA) for use in PET scans, specifically for detecting prostate cancer lesions.

Approved in the USA on May 27, 2021, Piflufolastat F 18 is intended for men with prostate cancer who have suspected metastasis or recurrence, providing a valuable tool for guiding treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. Keam, SJ.[2022]

The new PET agent 18F-DCFPyL, which targets prostate-specific membrane antigen (PSMA), has shown superior diagnostic accuracy compared to conventional imaging methods for staging and restaging prostate cancer, as demonstrated in the OSPREY and CONDOR clinical trials.

The use of PSMA-PET imaging is expected to significantly enhance prostate cancer management and may lead to new diagnostic and therapeutic opportunities, improving overall patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . Voter, AF., Werner, RA., Pienta, KJ., et al.[2022]

The 18F-labeled PSMA-directed PET agent [18F]DCFPyL (PYLARIFY) has shown significant clinical utility in staging and restaging prostate cancer, supported by major trials like OSPREY and CONDOR.

Following its recent FDA approval, [18F]DCFPyL is expected to see increased adoption for imaging and management of prostate cancer, enhancing image-guided treatment strategies in both the U.S. and Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. Rowe, SP., Buck, A., Bundschuh, RA., et al.[2022]

Piflufolastat F 18 is a highly effective PET radiotracer for prostate cancer diagnosis, providing the highest life-years (6.80) and quality-adjusted life-years (5.33) compared to other imaging options like fluciclovine F 18 and PSMA 11.

In terms of cost-effectiveness, piflufolastat F 18 demonstrated lower incremental cost-effectiveness ratios (ICERs) than its competitors, making it a financially favorable choice for prostate cancer diagnosis in the US healthcare system.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Positron Emission Tomography with Piflufolastat F 18 for the Initial Diagnosis of Patients with Prostate Cancer in the United States. Yee, CW., Harvey, MJ., Xin, Y., et al.[2023]

In a study of 253 patients with biochemically recurrent hormone-sensitive prostate cancer, 40.7% had a change in treatment management after undergoing 18F-DCFPyL PET/CT imaging, highlighting its significant impact on clinical decision-making.

Positive findings from the 18F-DCFPyL PET/CT scan and positive pathological lymph node status were strong predictors for changing treatment plans, while a positive surgical margin was associated with a lower likelihood of management change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study. Meijer, D., van Leeuwen, PJ., Oosterholt, PMJ., et al.[2021]

In a study of 235 patients undergoing F-18 PSMA PET imaging for prostate cancer, 65.5% had PSMA-avid lesions detected, indicating its effectiveness in identifying cancer spread.

The imaging led to changes in treatment plans for 54.5% of patients in the initial staging group and 33.9% in the biochemical recurrence group, demonstrating its significant impact on clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. Arafa, AT., Jain, A., Skrobanek, P., et al.[2023]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Piflufolastat F 18: Diagnostic First Approval. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

[18F]DCFPyL PET/CT for Imaging of Prostate Cancer. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Modeling of Prostate-Specific Membrane Antigen Positron Emission Tomography with Piflufolastat F 18 for the Initial Diagnosis of Patients with Prostate Cancer in the United States. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study. [2021]

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

Impact of piflufolastat F-18 PSMA PET imaging on clinical decision-making in prostate cancer across disease states: A retrospective review. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Two experts and a newbie: [18F]PARPi vs [18F]FTT vs [18F]FPyPARP-a comparison of PARP imaging agents. [2022]

8. 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]