18F-rhPSMA-7.3 PET-mpMRI for Prostate Cancer

Overseen By David M. Schuster, MD, FACR

Age: 18+

Sex: Male

Trial Phase: Phase 2

Sponsor: Emory University

Disqualifiers: Prostatitis, BPH, UTIs, hip prosthesis, 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

Compensation: Varies

Number of Visits: 1

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.

Will I have to stop taking my current medications?

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 or your doctor.

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

Research shows that a similar drug, 18F-DCFPyL, is effective in improving the detection of prostate cancer by targeting PSMA, which is present in nearly all prostate cancers. This improved imaging helps in better staging and management of the disease. ^{1 2 3 4 5}

Is 18F-rhPSMA-7.3 (Flotufolastat F-18 Gallium) safe for use in humans?

Flotufolastat F 18, also known as POSLUMA, has been approved in the USA as a diagnostic agent for imaging prostate cancer, indicating it has undergone safety evaluations for human use. ^{1 2 4 6 7}

How is the treatment 18F-rhPSMA-7.3 PET-mpMRI different from other prostate cancer treatments?

18F-rhPSMA-7.3 PET-mpMRI is unique because it combines a novel PET radiopharmaceutical, 18F-rhPSMA-7.3, with multiparametric MRI to optimize imaging of prostate cancer, potentially offering more precise detection and monitoring compared to traditional imaging methods. ^{2 4 5 7 8}

Research Team

David M Schuster, MD, FACR

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

This trial is for men suspected to have prostate cancer. It's evaluating a new imaging technique that may improve the accuracy of identifying tumor tissue in the prostate. Participants should be candidates for a biopsy and willing to undergo advanced imaging procedures.

Inclusion Criteria

Patients must be able to provide written informed consent

I am a man over 18 years old.

I am suspected to have prostate cancer and will undergo a biopsy.

Exclusion Criteria

Patients with contraindications for MRI including implantable pace makers, cochlear implants

Subjects with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments

Is determined by the Investigator that the patient is clinically unsuitable for the study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Biopsy

Participants receive 18F-rhPSMA-7.3 intravenously and undergo PET-mpMRI imaging, followed by a TRUS-MR fusion biopsy if necessary

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging and biopsy

Up to 3 months

Treatment Details

Interventions

• Flotufolastat F-18 Gallium

Trial Overview The trial tests an investigational scan called 18F-rhPSMA-7.3 PET-mpMRI, which might better detect tumor tissue compared to standard mpMRI alone. The goal is to see if this new method can increase the precision of TRUS-MR fusion biopsies in locating abnormal prostate areas.

Participant Groups

Group I: Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy) Experimental Treatment 5 Interventions

Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

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 study developed new fluorine-containing imaging agents that can potentially allow for noninvasive imaging of androgen receptor-positive prostate cancer, which is crucial since 80-90% of prostate cancers depend on androgens.

These imaging agents were successfully synthesized with high radiochemical purity and yield, suggesting they could be used for quantitative molecular imaging and possibly guide treatment decisions in prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer PET bioprobes: synthesis of [18F]-radiolabeled hydroxyflutamide derivatives. Jacobson, O., Bechor, Y., Icar, A., et al.[2016]

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]

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]

The PET imaging agent N-3-[18F]fluoropropylputrescine shows promising results for targeting prostate tumors, with a radiochemical yield of 7-10% and a specific activity exceeding 1.1 Ci/mumol after a synthesis time of 1.5 hours.

In vivo studies in male rats demonstrated high uptake in the prostate, especially when pretreated with specific compounds, suggesting that this agent could effectively differentiate prostate tissue from surrounding muscle and blood, enhancing its potential as a diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. Hwang, DR., Lang, LX., Mathias, CJ., et al.[2016]

The novel PET radiopharmaceutical 18F-rhPSMA-7.3 showed high uptake in prostate cancer lesions, with optimal visual detection starting at 60 minutes post-injection, indicating its potential effectiveness for imaging prostate cancer.

The study demonstrated that the lesion-to-background ratios increased significantly over time, suggesting that 18F-rhPSMA-7.3 could provide clearer imaging results for diagnosing prostate cancer, based on a phase 1 trial involving nine men with varying stages of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Kinetic analysis and optimisation of 18F-rhPSMA-7.3 PET imaging of prostate cancer. Malaspina, S., Oikonen, V., Kuisma, A., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Comparison of PSMA-based 18F-DCFPyL PET/CT and pelvic multiparametric MRI for lesion detection in the pelvis in patients with prostate cancer. [2023]

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

Prostate cancer recurrence in patients with negative or equivocal conventional imaging: A role for 18F-fluciclovine-PET/CT in delineating sites of recurrence and identifying patients with oligometastatic disease. [2022]

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

Prostate cancer PET bioprobes: synthesis of [18F]-radiolabeled hydroxyflutamide derivatives. [2016]

5. 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]

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

Flotufolastat F 18: Diagnostic First Approval. [2023]

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

N-3-[18F]fluoropropylputrescine as potential PET imaging agent for prostate and prostate derived tumors. [2016]

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

Kinetic analysis and optimisation of 18F-rhPSMA-7.3 PET imaging of prostate cancer. [2022]