Actively Recruiting
An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-11-10
81
Participants Needed
1
Research Sites
576 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
This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. 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 other methods.
CONDITIONS
Official 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 study enrollment
- History of prostate cancer
- Men who received focal therapy (laser, cryotherapy, high-intensity focused ultrasound [HIFU], Tulsa Pro, irreversible electroporation [IRE], or 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 less than 24 hours before the PET scan
- Patients with castrate levels of testosterone due to androgen deprivation therapy
- Inability to provide written informed consent
- Known inability to remain still and lie flat for about 30 minutes during PET/CT
- Use of any investigational agents within 42 days before the first dose
- Unable to understand or follow study instructions, including inability to complete imaging or biopsy due to conditions such as severe claustrophobia or inability to lie still or raise arms during imaging procedures
AI-Screening
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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
CONTACT
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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