PET/CT Imaging for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new imaging method using a special PET/CT scan with the imaging agent Flotufolastat F18 to determine if it can better detect significant prostate cancer compared to the usual MRI scan. It targets men diagnosed with low-risk or favorable intermediate-risk prostate cancer who are currently monitored rather than treated aggressively. Participants will undergo both the new PET/CT scan and an MRI before a follow-up biopsy. Men diagnosed with prostate cancer through a biopsy and managing it with active surveillance might be suitable candidates. The goal is to determine if this new scan can identify important cancer signs that the MRI might miss. As a Phase 2 trial, this research focuses on assessing the effectiveness of the new imaging method in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this imaging technique is safe for prostate cancer patients?
Research shows that flotufolastat F18, also known as POSLUMA®, is generally safe for men with prostate cancer. Studies have found that this imaging agent has a good safety record, with most patients not experiencing significant side effects. This indicates its safety for individuals with prostate cancer.
Flotufolastat F18 enhances the clarity of prostate cancer scans. It has been used in other prostate cancer studies and demonstrated positive results without causing major problems for patients. Based on this evidence, this treatment appears safe for use in clinical trials.12345Why are researchers excited about this trial?
Flotufolastat F18 is unique because it uses a special radioactive tracer, rhPSMA-7.3 (¹⁸F), in PET/CT imaging to target prostate-specific membrane antigen (PSMA), a protein commonly found on prostate cancer cells. Unlike traditional imaging methods like standard multiparametric MRI, this technique can potentially provide clearer and more precise images of prostate cancer. Researchers are excited about this treatment because it could improve the accuracy of prostate cancer detection and staging, leading to better-informed treatment decisions.
What evidence suggests that rhPSMA-7.3 (¹⁸F) PET/CT imaging is effective for detecting prostate cancer?
Research shows that flotufolastat F18, also known as POSLUMA®, can effectively detect prostate cancer. One study found that this imaging agent identified cancer sites more accurately than traditional imaging methods. In this trial, participants will undergo rhPSMA-7.3 (¹⁸F) PET/CT imaging with flotufolastat F18, alongside standard multiparametric MRI, before confirmatory prostate biopsy. Previous studies have shown that flotufolastat F18 PET scans helped doctors manage prostate cancer better by providing clearer images of cancer locations. Additionally, using this PET/CT imaging method led to better outcomes for patients with recurring prostate cancer. This approach offers a more precise way to diagnose, aiding doctors in making better treatment decisions.13467
Who Is on the Research Team?
Ashutosh Tewari
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
Men with low-risk or favorable intermediate-risk prostate cancer who are on active surveillance can join this study. They must have biopsy-proven prostate cancer and be eligible for MRI and confirmatory biopsy procedures.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Imaging
Participants undergo rhPSMA-7.3 (¹⁸F) PET/CT and multiparametric MRI prior to confirmatory biopsy
Confirmatory Biopsy
Participants undergo a confirmatory prostate biopsy targeting areas identified on MRI, PET/CT, or both
Follow-up
Participants are monitored for safety and effectiveness after imaging and biopsy
What Are the Treatments Tested in This Trial?
Interventions
- Flotufolastat F18
Trial Overview
The trial is testing the diagnostic effectiveness of a PET/CT scan using rhPSMA-7.3 (18F) alongside standard MRI to improve detection of significant prostate cancer in men under active surveillance, compared to MRI alone.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants in this arm will undergo rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, POSLUMA®) imaging and standard multiparametric MRI prior to confirmatory prostate biopsy. All participants receive the same imaging procedures; there are no control or comparison arms.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
Blue Earth Diagnostics
Industry Sponsor
Citations
True-Positive 18F-Flotufolastat Lesions in Patients with ...
F-flotufolastat may help to better define sites of disease recurrence and inform salvage therapy decisions than does conventional imaging, ...
Impact of 18F-flotufolastat PET on management of patients ...
Results: Of 389 patients who had 18F-flotufolastat PET, 97 had sufficient MP data for evaluation. These 97 patients were comparable to the ...
Diagnostic Utility of rhPSMA-7.3 (18F) PET/CT in Men With ...
This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, ...
Biochemical failure-free survival of 18 F-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 ...
POSLUMA® (flotufolastat F 18) injection
The efficacy and safety of POSLUMA were evaluated in two studies, one each in men with newly diagnosed prostate cancer and biochemical ...
Safety
Learn about the established safety and tolerability of POSLUMA® (flotufolastat F 18) Injection in men with prostate cancer.
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targetedonc.com
targetedonc.com/view/nccn-guidelines-add-flotufolastat-f-18-injection-for-prostate-cancerNCCN Guidelines Add Flotufolastat F 18 Injection for ...
Data from 2 studies, LIGHTHOUSE and SPOTLIGHT, have shown the benefit of flotufolastat F 18 injection as a radiohybrid PSMA-targeted pet ...
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