An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.
NCT ID: NCT07185165
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
81 participants
INTERVENTIONAL
2025-10-09
2036-10-25
Brief Summary
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Detailed Description
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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.
SECONDARY OBJECTIVE:
I. To evaluate the standard uptake volume (SUV) threshold of flotufolastat F 18 compared to Gleason score.
EXPLORATORY OBJECTIVE:
I. To compare how flotufolastat F 18 and gallium Ga 68 gozetotide (Ga 68 PSMA 11) are distributed within the prostate in men who have previously undergone focal therapy.
OUTLINE:
Patients receive flotufolastat F-18 intravenously (IV). Then 50-100 minutes after injection, patients undergo whole-body PET/CT over 20-50 minutes. Patients then undergo PET/CT/ultrasound fusion biopsy within 3 months.
After completion of study intervention, patients are followed up at 1 month post-biopsy and then every 12 months for up to 10 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (flotufolastat F-18 PET/CT)
Patients receive flotufolastat F-18 IV. Then 50-100 minutes after injection, patients undergo whole-body PET/CT over 20-50 minutes. Patients then undergo PET/CT/ultrasound fusion biopsy within 3 months.
Computed Tomography
Undergo PET/CT
Fluorine F 18 Flotufolastat
Given IV
Positron Emission Tomography
Undergo PET/CT
Ultrasound-Guided Prostate Biopsy
Undergo PET/CT/ultrasound fusion biopsy
Interventions
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Computed Tomography
Undergo PET/CT
Fluorine F 18 Flotufolastat
Given IV
Positron Emission Tomography
Undergo PET/CT
Ultrasound-Guided Prostate Biopsy
Undergo PET/CT/ultrasound fusion biopsy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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)
18 Years
90 Years
MALE
No
Sponsors
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Blue Earth Diagnostics
INDUSTRY
Jonsson Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Wayne Brisbane
Role: PRINCIPAL_INVESTIGATOR
UCLA / Jonsson Comprehensive Cancer Center
Locations
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UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States
Countries
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Central Contacts
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Facility Contacts
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Kyla Grunden
Role: primary
Other Identifiers
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NCI-2025-06280
Identifier Type: REGISTRY
Identifier Source: secondary_id
24-1371
Identifier Type: -
Identifier Source: org_study_id