New PSMA PET/CT (flotufolastat F-18) compared with MRI to find prostate cancer
Beacon: Prospective Assessment of Flotufolastat F 18 PSMA and MRI in the Diagnosis of Clinically Significant Prostate Cancer
We are testing whether a PSMA PET/CT scan using flotufolastat F-18 can better guide targeted prostate biopsies in men with prostate cancer who have a suspicious MRI lesion (PI-RADS 3-5).
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Male |
| Sponsor | Jonsson Comprehensive Cancer Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT07164027 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Men aged 18 to 90 who have at least one PI-RADS 3-5 lesion on MRI within the past 12 months and who can undergo PET/CT and prostate biopsy are ideal candidates.
Not a fit: Men who have had prior treatment for prostate cancer, cannot stop blood thinners, or have contraindications to PET/CT or ultrasound-guided biopsy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could locate clinically significant prostate cancer more accurately and help reduce unnecessary systematic biopsies.
How similar studies have performed: PSMA PET imaging has shown promising results in detecting prostate cancer in other studies, but using flotufolastat F-18 specifically to guide targeted prostate biopsies is relatively new and still being tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.