PSMA Imaging for Prostate Cancer

Overseen By Kyla Grunden

Age: 18+

Sex: Male

Trial Phase: Phase < 1

Sponsor: Jonsson Comprehensive Cancer Center

Must not be taking: Blood thinners, investigational agents

Disqualifiers: Previous prostate cancer treatment, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for using imaging scans to help doctors obtain better prostate cancer samples. It employs a special imaging agent called flotufolastat F 18, a radiotracer that highlights cancer cells on PET/CT scans. These scans are combined with ultrasound images during a biopsy. The goal is to determine if this method detects more cancer than the usual MRI-guided biopsies. Men with a specific type of prostate lesion (PI-RADS 3-5) on an MRI scan from the past year may qualify for this trial. As an Early Phase 1 trial, this research aims to understand how this new imaging method functions in people, offering participants a chance to be among the first to benefit from this innovative approach.

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

The trial requires you to stop taking blood thinners for 7 days before the biopsy. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

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

Research has shown that flotufolastat F 18, the imaging agent used in this trial, has been tested for safety in men with prostate cancer. Previous studies, such as the LIGHTHOUSE and SPOTLIGHT studies, indicated that this agent is generally well-tolerated, with most patients not experiencing major side effects.

In this trial, it is important to note that flotufolastat F 18 has already received FDA approval for detecting prostate cancer, though not specifically for guiding biopsies. This approval provides reassurance about its safety.

Although using any radioactive material might seem concerning, the amounts used in PET/CT imaging are very small and considered safe. This imaging method helps doctors see prostate cancer cells more clearly, potentially leading to more accurate biopsies. Overall, flotufolastat F 18 has demonstrated promise as a tool with a good safety record in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Flotufolastat F-18 is unique because it targets prostate-specific membrane antigen (PSMA), providing a more precise imaging method for detecting prostate cancer. Unlike traditional imaging techniques, such as bone scans or CT scans, this treatment uses a radioactive tracer to bind specifically to PSMA, allowing for clearer and more accurate images of cancer spread. Researchers are excited about this method because it could lead to better detection and staging of prostate cancer, potentially improving treatment decisions and outcomes for patients.

What evidence suggests that this imaging technique is effective for guiding prostate biopsies?

Research has shown that flotufolastat F-18, the imaging agent used in this trial, effectively detects prostate cancer. In studies, this agent detected cancer recurrence in about two-thirds of patients with very low PSA (prostate-specific antigen) levels, which is impressive for early detection. It binds strongly to prostate cancer cells with PSMA, making them visible during PET/CT scans. This visibility aids doctors in targeting the correct area during prostate biopsies. Overall, flotufolastat F-18 can enhance cancer detection and may assist in planning more effective treatments. ^{6 7 8 9 10}

Who Is on the Research Team?

Wayne Brisbane

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

Men with prostate cancer are eligible for this trial, which tests a new imaging technique to guide biopsies. Participants should be candidates for biopsy and have not undergone treatments that might interfere with the imaging agent.

Inclusion Criteria

Have at least one PI-RADS 3-5 lesion on MRI within the 12 months prior to enrollment

I am a man aged between 18 and 90.

Exclusion Criteria

Any investigational agents within 42 days prior to the day of the first dose

I cannot have a fluciclovine F 18 PET CT scan due to health reasons.

I cannot have a prostate biopsy using ultrasound.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Imaging and Biopsy Preparation

Participants receive flotufolastat F-18 intravenously and undergo PET/CT imaging over 30 minutes

1 day

Biopsy

Participants undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order

Within 6 months of PET/CT imaging

Follow-up

Participants are monitored for safety and effectiveness after biopsy

3 months initially, then every 12 months for up to 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Flotufolastat F-18 Gallium

Trial Overview The BEACON trial is evaluating flotufolastat F-18 combined with PET/CT scanning versus MRI to improve prostate cancer detection during biopsies. It aims to see if this new method can better identify and inform about cancer risk.

How Is the Trial Designed?

Group I: Diagnostic (flotufolastat F-18 PET/CT) Experimental Treatment 5 Interventions

Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

BLUE EARTH DIAGNOSTICS (UNITED KINGDOM)

Collaborator

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110065/

Detection Rates of PSMA-PET Radiopharmaceuticals in ... Moreover, the sample-weighted mean data reveal that 18F-flotufolastat identified recurrence in two-thirds of patients with a PSA level < 1 ng/mL ...

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

Biochemical failure-free survival of 18F-rhPSMA-7 and ... F-Flotufolastat and 18F-rhPSMA-7 PET-guided SRT result in favorable disease outcomes in patients with biochemical recurrence of prostate cancer ...

3. urotoday.com urotoday.com/library-resources/imaging-center/157319-new-pet-imaging-tracers-for-the-primary-staging-of-unfavorable-intermediate-and-high-risk-prostate-cancer.html

New PET Imaging Tracers for the Primary Staging of ... Flotufolastat F 18 demonstrates high PSMA binding affinity, high internalization by PSMA-expressing cells, medium-to-low lipophilicity, and high human serum ...

4. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2023/216023Orig1s000MultidisciplineR.pdf

216023Orig1s000 - accessdata.fda.gov Supportive data for the biodistribution of flotufolastat F 18 in patients with prostate cancer are provided from two retrospective chart ...

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/safety/

Safety Learn about the established safety and tolerability of POSLUMA® (flotufolastat F 18) Injection in men with prostate cancer.

8. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07185165

An Investigational Scan (Flotufolastat F 18 PET/CT) for ... Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11578810/

Normal-organ distribution of PSMA-targeting PET ... Data from the Phase 3 LIGHTHOUSE and SPOTLIGHT studies show 18F-flotufolastat to be well tolerated and to provide clinically useful information regarding ...

10. mayoclinic.org mayoclinic.org/drugs-supplements/flotufolastat-f-18-intravenous-route/description/drg-20551214

Flotufolastat f 18 (intravenous route) - Side effects & uses ... prostate cancer. It is given in patients with suspected metastasis ... Safety and efficacy have not been established. Geriatric.