18F-labeled PET Imaging for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Herbert Lepor, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: NYU Langone Health

Disqualifiers: Mri contraindication, Allergic to rhpsma-7.3, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

All men following Radical Prostatectomy (RP) at NYU Langone Health undergo routine prostate specific antigen (PSA) testing in order to identify disease recurrence. By consensus, a BCR following RP occurs once the PSA \> 0.2 ng/ml/ Biochemical recurrence often develops years prior to clinical evidence of disease recurrence. Early identification of the site(s) of disease recurrence enables early salvage intervention. Men will be eligible for the study at the point in time their post-prostatectomy PSA level first becomes \>0.2 ng/ml. Only those patients with rhPSMA-7.3 (18F) identifiable disease (local, nodal or systemic) will be offered salvage intervention per standard of care. All patients with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA is \> 0,5 ng/ml or one year after the initial PET study. The salvage interventions will be at the discretion of the investigator. The study will compare the diagnostic yield of the first and second rhPSMA-7.3 (18F) studies.

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Flotufolastat F 18 for prostate cancer?

Flotufolastat F 18 has been approved in the USA as a diagnostic agent for imaging prostate cancer, specifically for detecting PSMA positive lesions in men with suspected metastasis or recurrence. This approval suggests that it is effective in helping doctors see where prostate cancer might have spread, which can guide treatment decisions. ^{1 2 3 4 5}

Is 18F-labeled PET Imaging for Prostate Cancer safe for humans?

Flotufolastat F 18, also known as Posluma, is approved in the USA as a diagnostic agent for prostate cancer imaging, indicating it has been evaluated for safety in humans. While specific safety data is not detailed in the provided research, the approval suggests it has met safety standards for use in prostate cancer imaging. ^{1 2 3 4 6}

How does the drug 18F-labeled PET Imaging for Prostate Cancer differ from other treatments?

The drug 18F-labeled PET Imaging for Prostate Cancer, specifically flotufolastat F 18, is unique because it targets prostate-specific membrane antigen (PSMA) for improved imaging of prostate cancer. This allows for more accurate detection of cancer spread compared to conventional imaging methods, which often have limited sensitivity for detecting metastatic disease. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for men aged 18-100 who've had prostate removal surgery and now have a PSA level over 0.2 ng/ml, indicating potential cancer recurrence. It's not for those with MRI contraindications, previous allergic reactions to rhPSMA-7.3 (18F), or refusal of PET/MRI scans.

Inclusion Criteria

I am a man aged 18-100 and my PSA level rose above 0.2 ng/ml after prostate surgery.

Exclusion Criteria

Prior allergic reaction to rhPSMA-7.3 (18F)

I do not want to undergo a rhPSMA-7.3 (18F) PET/MRI scan.

Any contraindication for MRI imaging

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Imaging

Participants receive a baseline rhPSMA-7.3 (18F) MRI scan to identify disease recurrence

1 month

1 visit (in-person)

Follow-up Imaging

Participants undergo a second rhPSMA-7.3 (18F) scan if initial scan is negative, when PSA > 0.5 ng/ml or one year after the initial scan

Up to 12 months

1 visit (in-person)

Salvage Intervention

Participants with identifiable disease during the initial scan are offered salvage intervention per standard of care

Follow-up

Participants are monitored for safety and effectiveness after intervention

Up to 24 months

Treatment Details

Interventions

• 18F-Labeled Positron Emission Tomography (PET) Diagnostic Agent (Diagnostic Agent)
• PET MRI Imaging (Imaging)

Trial Overview The study tests the timing of a diagnostic agent called rhPSMA-7.3 (18F) in combination with PET MRI imaging to detect recurrent prostate cancer after surgery. It compares the effectiveness at two different PSA levels: >0.2 ng/ml and >0.5 ng/ml or one year later.

Participant Groups

Group I: Patients with PSA > 0.2 ng/ml following Radical Prostatectomy Experimental Treatment 2 Interventions

Men will be eligible for the study when their post-prostatectomy PSA level is initially observed to be PSA \>0.2ng/ml. All participants will receive a baseline rhPSMA-7.3 (18F) MRI scan within a month of enrollment, and the second rhPSMA-7.3 (18F) scan will be performed within a year of the initial scan. Only those participants with rhPSMA-7.3 (18F) identifiable disease during the initial scan will be offered salvage intervention per standard of care. All participants with a negative initial rhPSMA-7.3 (18F) scan will undergo a second scan when the PSA\> 0.5 ng/ml or one year after the initial PET scan. The salvage intervention will be at the discretion of the investigator.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Smilow Comprehensive Prostate Cancer Center New York, NY

Who Is Running the Clinical Trial?

NYU Langone Health Lead Sponsor

Blue Earth Diagnostics Industry Sponsor

References

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

Flotufolastat F 18: Diagnostic First Approval. [2023] Flotufolastat F 18 (POSLUMA®) is an 18F-labelled radiohybrid (rh) prostate-specific membrane antigen (PSMA)-targeted imaging agent being developed by Blue Earth Diagnostics, a subsidiary of Bracco Imaging, for prostate cancer imaging. In May 2023, flotufolastat F 18 received its first approval in the USA as a radioactive diagnostic agent for positron emission tomography (PET) of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level. This article summarizes the milestones in the development of flotufolastat F 18 leading to this first approval.

2. 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] Piflufolastat F-18 (18F-DCFPyL) prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging is approved by the US food and drug administration for initial staging of high-risk prostate cancer, biochemical recurrence (BCR), and restaging of metastatic prostate cancer. Here, we sought to assess how its integration into clinical care may have impacted the management of patients.

3. 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] Piflufolastat F 18 is a novel prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) radiotracer that is superior to standard of care (SOC) imaging for the initial staging of prostate cancer and the detection of biochemical recurrence. As piflufolastat F 18 has been approved in the United States (US) for this indication, this modeling study assessed the cost effectiveness of piflufolastat F 18 versus fluciclovine F-18, gallium68-PSMA-11 (PSMA 11), and SOC imaging (a mix of bone scans, computed tomography, and magnetic resonance imaging) for the diagnosis and staging of prostate cancer from a US healthcare system perspective.

4. England pubmed.ncbi.nlm.nih.gov

Piflufolastat F-18 (18F-DCFPyL) for PSMA PET imaging in prostate cancer . [2022] Label="INTRODUCTION">Accurate imaging is essential for staging prostate cancer and guiding management decisions. Conventional imaging modalities are hampered by a limited sensitivity for metastatic disease. Nearly all prostate cancers express prostate-specific membrane antigen (PSMA) and 18F-DCFPyL (piflufolastat F 18) is a new FDA-approved positron emission tomography (PET) agent that targets PSMA for improved staging of prostate cancer.

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

Piflufolastat F 18: Diagnostic First Approval. [2022] Piflufolastat F 18 (PYLARIFY®) is an 18F-labelled diagnostic imaging agent that has been developed by Progenics Pharmaceuticals Inc., a Lantheus company, for positron emission tomography (PET) that targets prostate-specific membrane antigen (PSMA). Piflufolastat F 18 was approved in the USA on 27 May 2021 for PET of PSMA positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum prostate specific antigen (PSA) level. This article summarizes the milestones in the development of piflufolastat F 18 leading to this approval as a radioactive diagnostic agent in prostate cancer.

6. Canada pubmed.ncbi.nlm.nih.gov

Image acquisition and interpretation of 18F-DCFPyL (piflufolastat F 18) PET/CT: How we do it. [2023] Prostate-specific membrane antigen (PSMA)-targeted positron emission tomography (PET) is rapidly becoming widely accepted as the standard-of-care for imaging of men with prostate cancer. Labeled indications for regulatoryapproved agents include primary staging and recurrent disease in men at risk of metastases. The first commercial PSMA PET agent to become available was 18F-DCFPyL (piflufolastat F 18), a radiofluorinated small molecule with high-affinity for PSMA. The regulatory approval of 18F-DCFPyL hinged upon two key, multi-center, registration trials, OSPREY (patient population: highrisk primary staging) and CONDOR (patient population: biochemical recurrence). In this manuscript, we will (1) review key findings from the OSPREY and CONDOR trials, (2) discuss the clinical acquisition protocol we use for 18F-DCFPyL PET scanning, (3) present information on important pearls and pitfalls, (4) provide an overview of the PSMA reporting and data system (PSMA-RADS) interpretive framework, and (5) posit important future directions for research in PSMA PET. Our overall goal is to provide a brief introduction for practices and academic groups that are adopting 18F-DCFPyL PET scans for use in their patients with prostate cancer.