New PSMA PET/CT (flotufolastat F-18) compared with MRI to find prostate cancer

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

This early Phase I interventional study gives participants an IV injection of flotufolastat F-18 followed by PET/CT imaging, then performs both PSMA PET/CT/ultrasound fusion biopsy and MRI/ultrasound fusion biopsy in a randomized order within six months. The trial compares detection rates for clinically significant prostate cancer (grade group ≥2) between PSMA PET and MRI ROIs, and examines relationships between SUV, PI-RADS scores, and the potential to omit systematic biopsy. Secondary and exploratory goals include characterizing incidental GG1 detection, concordance of tumor location between methods, validating an MRI+PSMA composite score, and comparing aggressiveness and tumor volume identified by each modality. Blood samples and biopsy biospecimens may be collected for correlative analyses.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men aged 18-90 at study enrollment
* Have at least one PI-RADS 3-5 lesion on MRI within the 12 months prior to enrollment

Exclusion Criteria:

* Contraindication to flotufolastat F 18 PET CT
* Contraindication to ultrasound-guided prostate biopsy
* Previous treatment of prostate cancer
* Unable to discontinue blood thinners for 7 days prior to biopsy
* 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.