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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to more accurately detect prostate cancer. It combines a PET scan, which uses a small amount of radioactivity to highlight tumors, with mpMRI, a detailed scan that distinguishes between healthy and cancerous tissue. The PET scan uses Flotufolastat F-18 Gallium, a radioactive tracer, to enhance imaging. Researchers aim to determine if this combined imaging can better pinpoint cancerous tissue compared to the standard MRI alone. Men who might be suitable for this trial are those who suspect they have prostate cancer and plan to have a biopsy for confirmation. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

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 prior data suggests that this imaging technique is safe for identifying prostate cancer?

Research has shown that the imaging agent 18F-rhPSMA-7.3, also known as Flotufolastat F-18 Gallium, is safe and well-tolerated in people. A study with 747 prostate cancer patients thoroughly assessed its safety, with side effects reported in less than 0.4% of patients.

This FDA-approved imaging method for detecting prostate cancer uses a small amount of radioactivity to highlight cancer cells. It is highly sensitive, effectively identifying signs of cancer.

Overall, evidence suggests that Flotufolastat F-18 Gallium is generally safe for prostate cancer imaging, with very few side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-rhPSMA-7.3 PET-mpMRI technique because it offers a more precise way of detecting prostate cancer compared to traditional methods like standard mpMRI alone. This method uses Flotufolastat F-18, a radioactive tracer that specifically targets prostate-specific membrane antigen (PSMA), allowing for clearer imaging of cancerous tissues. This targeted approach could lead to more accurate diagnoses and better-informed treatment decisions, potentially improving outcomes for patients with prostate cancer.

What evidence suggests that this imaging technique is effective for identifying prostate cancer?

Research has shown that 18F-rhPSMA-7.3, also known as flotufolastat F-18, effectively detects prostate cancer. Studies have found it to be highly sensitive, identifying cancer even when other methods fail. In one study, this imaging technique detected cancer in patients who had negative results with standard imaging, indicating its ability to catch otherwise missed cases. Overall, flotufolastat F-18 appears promising for early prostate cancer detection, which is crucial for treatment. Participants in this trial will receive 18F-rhPSMA-7.3 as part of the diagnostic process. ^{3 4 6 7 8}

Who Is on the Research Team?

David M Schuster, MD, FACR

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

Citations

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Impact of Clinical Factors on 18F-Flotufolastat Detection Rates ... 18 F-Flotufolastat-positron emission tomography enabled the accurate detection of recurrent PCa lesions across a wide range of PSA, PSAdt, and International ...

2. nature.com nature.com/articles/s41598-024-83074-3

Biochemical failure-free survival of 18F-rhPSMA-7 and ... Early clinical retrospective data demonstrate both 18F-rhPSMA-7 and 18F-flotufolastat to have high sensitivity for the detection of prostate ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06617481

PET Scan Study to Detect Prostate Cancer in Patients with ... The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2024/05/23/jnumed.123.267271

True-Positive 18F-Flotufolastat Lesions in Patients with ... 18 F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging.

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.4_suppl.TPS347

Role of 18F-flotufolastat PET/CT imaging in men with high- ... This is a multicenter, prospective, randomized study comparing 18F-flotufolastat PET/CT to conventional imaging for staging men with high-risk PCa.

6. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2023/216023s000lbl.pdf

Page 1 of 12 - accessdata.fda.gov Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues.

7. posluma.com posluma.com/POSLUMA_Clinical_Summary.pdf

POSLUMA® (flotufolastat F 18) injection POSLUMA SAFETY PROFILE. The safety of POSLUMA was evaluated in 747 patients with prostate cancer. The adverse reactions reported in ≥0.4% of ...

8. targetedonc.com targetedonc.com/view/nccn-guidelines-add-flotufolastat-f-18-injection-for-prostate-cancer

NCCN Guidelines Add Flotufolastat F 18 Injection for ... Data from the study showed the agent to have high detection rates (88%) compared with a correct detection rate of 57%, even in patients with low ...