Flotufolastat F18 PET/CT to find residual or recurrent prostate cancer after focal therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants receive an IV injection of flotufolastat F18 and undergo whole-body PET/CT about 50–100 minutes later, with imaging lasting roughly 20–50 minutes. Within three months of imaging, participants undergo PET/CT–ultrasound fusion guided prostate biopsy to confirm presence or absence of cancer. The primary aim is to compare the accuracy of flotufolastat F18 PET/CT against prostate biopsy for determining treatment success after focal therapy, and the secondary aim is to relate PET standardized uptake values (SUV) to Gleason score. An exploratory objective compares intraprostatic distribution of flotufolastat F18 with Ga‑68 PSMA‑11 in men previously treated with focal therapies, and participants are followed for outcomes for up to 10 years.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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)

Where it's running

• UCLA / Jonsson Comprehensive Cancer Center
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Wayne Brisbane — UCLA / Jonsson Comprehensive Cancer Center
• Study coordinator: Kyla Grunden
• Email: kgrunden@mednet.ucla.edu
• Phone: 310-206-7576

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.