Actively Recruiting
Eclipse: Flotufolastat F 18 PET/CT to Detect Residual or Recurrent Prostate Cancer After Focal Therapy
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-11-10
81
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
B
Blue Earth Diagnostics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the accuracy of flotufolastat F 18 PET/CT imaging to detect remaining or returning prostate cancer after focal therapy. This phase II trial focuses on men who have undergone focal treatments like laser or cryotherapy within the past 6 to 36 months. Flotufolastat F 18 binds to a protein on prostate cancer cells, allowing the imaging to highlight cancer areas by combining metabolic and anatomical information from PET and CT scans. Participants receive an intravenous injection of flotufolastat F 18, followed by a whole-body PET/CT scan 50 to 100 minutes later lasting 20 to 50 minutes. Within three months after imaging, they undergo a PET/CT/ultrasound fusion-guided prostate biopsy. After these procedures, follow-up visits occur one month post-biopsy and then annually for up to ten years to monitor outcomes. During the study, researchers assess how accurately the imaging detects prostate cancer compared to biopsy results and examine the optimal imaging uptake thresholds related to cancer severity. The study also explores how flotufolastat F 18 distributes in the prostate compared to another tracer. Safety and effectiveness are monitored through these imaging and biopsy procedures, with long-term observation extending up to ten years.
CONDITIONS
Brief Title
An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men aged 18 to 90 years at enrollment
- History of prostate cancer
- Have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound, Tulsa Pro, irreversible electroporation, brachytherapy) within 6 to 36 months before enrollment
You will not qualify if you...
- Contraindication to flotufolastat F 18 PET CT
- Contraindication to ultrasound-guided prostate biopsy
- Planned use of x-ray contrast agent or other PET radiotracer within 24 hours before the PET scan
- Castrate levels of testosterone due to androgen deprivation therapy
- Unable to provide written informed consent
- Unable to remain still and lie flat for about 30 minutes during PET/CT
- Use of investigational agents within 42 days before the first dose
- Unable to understand or follow study instructions or complete imaging and biopsy procedures (e.g., severe claustrophobia, inability to lie still, conditions preventing raised arms position)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive an intravenous injection of flotufolastat F-18 followed by a whole-body PET/CT scan. Within 3 months, participants then undergo a PET/CT/ultrasound fusion prostate biopsy to detect residual or recurrent prostate cancer.
1 injection and PET/CT scan visit and 1 biopsy visit
Duration - Up to 10 years
After the diagnostic procedures, participants have follow-up visits to monitor their condition and outcomes for up to 10 years.
1 visit at 1 month post-biopsy and annual visits every 12 months thereafter
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
Research Team
K
Kyla Grunden
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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