Flotufolastat F 18 for Prostate Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new scan to detect serious prostate cancer in men with unclear MRI results. The focus is on using an imaging agent called 18F-rhPSMA-7.3 (also known as Flotufolastat F 18) with a PET-CT scan to determine if it outperforms MRIs and biopsies alone. Men who haven't had a prostate biopsy before, have recently undergone a specific type of MRI, and are scheduled for a biopsy might be suitable candidates. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in prostate cancer detection.
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 the 18F-rhPSMA-7.3 PET-CT scan is safe for detecting prostate cancer?
Research has shown that the treatment 18F-rhPSMA-7.3 is generally well-tolerated by patients. One study found it effectively detects prostate cancer without causing major side effects. Safety tests revealed that participants managed the treatment well, with no serious adverse effects reported.
Moreover, 18F-rhPSMA-7.3 is already approved for detecting prostate cancer, indicating it has undergone prior safety studies. This approval suggests it is considered safe for use under a doctor's care. For concerns about side effects, discussing them with a doctor is advisable.12345Why are researchers excited about this trial?
Unlike the standard imaging techniques for prostate cancer, the investigational treatment Flotufolastat F 18 uses a novel imaging agent called 18F-rhPSMA-7.3. This agent specifically targets the prostate-specific membrane antigen (PSMA), a protein highly expressed in prostate cancer cells. By binding directly to PSMA, this approach promises more precise and detailed imaging, potentially leading to better diagnosis and treatment planning. Researchers are excited about this method because it could offer clearer images than current options, potentially improving the accuracy of detecting cancer spread.
What evidence suggests that the 18F-rhPSMA-7.3 PET-CT scan is effective for detecting prostate cancer?
Research has shown that 18F-rhPSMA-7.3, the imaging agent used in this trial, holds promise for more accurately detecting prostate cancer. Studies have found that this agent often identifies true cases of prostate cancer, even when other imaging methods miss them. When prostate cancer returns, it demonstrates a high detection rate, aiding in better disease management. This suggests it could be more effective than MRI alone at finding cancer, especially in unclear situations. Overall, these findings support using 18F-rhPSMA-7.3 to enhance the detection of serious prostate cancer.14678
Are You a Good Fit for This Trial?
This trial is for men over 18 who haven't had a prostate biopsy yet but have had an MRI in the last 90 days showing PIRADS 2 or 3 lesions, suggesting possible prostate cancer. They must be willing to sign consent and follow study procedures, and already scheduled for a targeted MRI/US biopsy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a PSMA PET scan after infusion of POSLUMA imaging agent
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- 18F-rhPSMA-7.3
Trial Overview
The trial is testing if a new PET-CT scan using Flotufolastat F 18 (POSLUMA®) can better identify serious prostate cancer compared to just having an MRI-guided biopsy. It's focused on patients with uncertain MRI results.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Eligible participants will undergo a PSMA PET scan after infusion of POSLUMA imaging agent.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Citations
Biochemical failure-free survival of 18F-rhPSMA-7 ... - Nature
F-Flotufolastat and 18F-rhPSMA-7 PET-guided SRT result in favorable disease outcomes in patients with biochemical recurrence of prostate cancer ...
True-Positive 18F-Flotufolastat Lesions in Patients with ...
18 F-flotufolastat frequently identified true-positive prostate cancer lesions in patients with negative conventional imaging.
Impact of 18F-flotufolastat PET on management of patients ...
Detection rate ofF-rhPSMA-7.3 PET in patients with suspected prostate cancer recurrence: Results from a phase 3, prospective, multicenter study ...
Impact of Clinical Factors on 18 F-Flotufolastat Detection ...
We present results of predefined exploratory endpoints from SPOTLIGHT to evaluate the impact of clinical factors on 18 F-flotufolastat detection rates (DR).
Prognostic 18 F-flotufolastat PET parameters for outcome ...
This retrospective analysis evaluates baseline 18 F-flotufolastat positron emission tomography (PET) parameters as prognostic parameters for treatment response ...
Safety, Biodistribution, and Radiation Dosimetry of 18F- ...
This first-in-humans study investigated the safety, biodistribution, and radiation dosimetry of a novel 18 F-labeled radiohybrid prostate-specific membrane ...
Diagnostic Performance and Safety of Positron Emission ...
Overall, 18F-rhPSMA-7.3-PET/CT was well tolerated, and identified N1 and M1 disease prior to surgery in newly diagnosed PCa patients. Patient summary. In order ...
Role of 18F-flotufolastat PET/CT imaging in men with high- ...
Background: 18F-Flotufolastat (18F-rhPSMA-7.3) is a prostate-specific membrane antigen (PSMA) ligand for the detection of prostate cancer (PCa).
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