An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.

{ "Investigational Scan for Prostate Cancer After Focal Therapy", "This study is testing a new type of scan called flotufolastat F 18 PET/CT. This scan helps doctors see if prostate cancer has returned or if any cancer cells are still present after you've had focal therapy (like laser, cryotherapy, or HIFU). Flotufolastat F 18 is a special tracer that attaches to prostate cancer cells, making them visible on the scan. The study aims to see how accurate this scan is compared to a prostate biopsy in finding cancer. You may be able to join if you are a man aged 18-90, have a history of prostate cancer, and had focal therapy between 6 and 36 months ago. The study plans to enroll 81 participants, but its current status is unclear.", "design": "This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 81 men.", "commitments": "You will receive an intravenous (IV) injection of flotufolastat F-18, followed by a whole-body PET/CT scan. You will also have a PET/CT/ultrasound fusion biopsy within 3 months.", "compensation": "Not stated in the trial record.", "follow_up": "You will be followed up at 1 month after your biopsy and then every 12 months for up to 10 years.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

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NCT07185165

An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.

Recruiting
PHASE2Ages 18–90InterventionalDiagnostic
Jonsson Comprehensive Cancer Center
~81 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Computed TomographyFluorine F 18 FlotufolastatPositron Emission TomographyUltrasound-Guided Prostate Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) positron emission tomography (PET)/computed tomography (CT) in detecting residual or recurrent prostate cancer lesions
Measured over Up to 10 years
Prostate Carcinoma
1 sites across 1 states
California1
  • Wayne Brisbane · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

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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)
  • Accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) positron emission tomography (PET)/computed tomography (CT) in detecting residual or recurrent prostate cancer lesionsUp to 10 years