Flotufolastat F 18 PET/CT for Prostate Cancer
(ECLIPSE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to detect prostate cancer that may persist or recur after certain treatments. It employs a special imaging technique called flotufolastat F 18 PET/CT, which combines structural images with signals from prostate cancer cells. The aim is to determine if this method can identify cancer more easily and efficiently than traditional methods. Men who have had prostate cancer and received treatments such as laser or cryotherapy in the past 6-36 months may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking investigational agents, you must stop them at least 42 days before the trial starts.
What prior data suggests that this imaging technique is safe for detecting prostate cancer?
Research has shown that flotufolastat F 18, a special dye used in PET/CT scans, is generally safe for patients. Studies have found that it effectively helps doctors identify prostate cancer spots. While primarily used for prostate cancer, it can also appear in other types of cancer, non-cancerous conditions, and normal tissues. Few reports of serious side effects exist, making it a promising tool for detecting disease. However, like any medical procedure, some mild side effects might occur, but they are usually easy to manage.12345
Why are researchers excited about this trial?
Flotufolastat F 18 is unique because it uses a radioactive tracer specifically designed for PET/CT imaging to detect prostate cancer more accurately. Unlike standard imaging options, which may include MRI or CT scans alone, this treatment involves a PET/CT scan that provides a more detailed view, potentially identifying cancerous cells that other methods might miss. Researchers are excited about this treatment because it could lead to earlier and more precise detection of prostate cancer, allowing for more tailored and effective treatment plans for patients.
What evidence suggests that flotufolastat F 18 PET/CT is effective for detecting residual or recurrent prostate cancer?
Research has shown that flotufolastat F 18 PET/CT, which participants in this trial will undergo, is promising for detecting prostate cancer that persists or returns after treatment. One study found it could reliably identify cancerous areas larger than 5 mm, aiding doctors in treatment decisions. Another study demonstrated that flotufolastat F 18 could detect cancer spread in many patients who had previously undergone surgery or radiation. These findings suggest that flotufolastat F 18 PET/CT could be an effective and less invasive method for identifying remaining or returning prostate cancer.16789
Who Is on the Research Team?
Wayne Brisbane
Principal Investigator
UCLA / Jonsson Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for prostate cancer patients who have finished focal therapy and are being checked for any remaining or returning cancer. It's not specified who can't join, but typically those with health conditions that could interfere with the scan or allergies to the tracer might be excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive flotufolastat F-18 intravenously and undergo whole-body PET/CT imaging
Biopsy
Participants undergo PET/CT/ultrasound fusion biopsy
Follow-up
Participants are monitored for safety and effectiveness after biopsy
What Are the Treatments Tested in This Trial?
Interventions
- Flotufolastat F 18
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jonsson Comprehensive Cancer Center
Lead Sponsor
BLUE EARTH DIAGNOSTICS (UNITED KINGDOM)
Collaborator
Blue Earth Diagnostics
Industry Sponsor