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Compensation: Varies

Number of Visits: 2

26 Participants Needed

18F-labeled PET Imaging for Prostate Cancer

Overseen ByMajlinda Tafa, MD

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: NYU Langone Health

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

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

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

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

Research Team

Herbert Lepor, MD

Principal Investigator

NYU Langone Medical Center

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

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
PET MRI Imaging

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Patients with PSA > 0.2 ng/ml following Radical ProstatectomyExperimental Treatment2 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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

Recruited

3,100+

Findings from Research

Flotufolastat F 18 (POSLUMA®) is a newly approved imaging agent specifically designed for detecting prostate cancer lesions using PET scans, particularly in men with suspected metastasis or recurrence.

The approval in May 2023 marks a significant milestone in prostate cancer diagnostics, allowing for better identification of PSMA positive lesions in patients who are candidates for definitive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flotufolastat F 18: Diagnostic First Approval.Heo, YA.[2023]

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]

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]