Status:
RECRUITING
An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.
Lead Sponsor:
Jonsson Comprehensive Cancer Center
Collaborating Sponsors:
Blue Earth Diagnostics
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18-90 years
Phase:
PHASE2
Brief Summary
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 (recu...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate the accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) compared with prostate biopsy to determine treatment success following focal therapy of the prostate...
Eligibility Criteria
Inclusion
- Men aged 18-90 at study enrollment
- History of prostate cancer
- Men who have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound \[HIFU\], Tulsa Pro, irreversible electroporation \[IRE\], brachytherapy) within 6-36 months of enrollment
Exclusion
- Contraindication to flotufolastat F 18 PET CT
- Contraindication to ultrasound-guided prostate biopsy
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer \< 24 hours prior to the PET scan
- Patients with castrate levels of testosterone secondary to androgen deprivation therapy
- Inability to provide written informed consent
- Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
- Any investigational agents within 42 days prior to the day of the first dose
- Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)
Key Trial Info
Start Date :
October 9 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 25 2036
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT07185165
Start Date
October 9 2025
End Date
October 25 2036
Last Update
November 10 2025
Active Locations (1)
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1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095