Not Yet RecruitingPhase 2

Utilization of Flotufolastat 18F PET for Post-Focal Therapy Prostate Cancer Evaluation

United States60 participantsStarted 2026-05

Plain-language summary

This is a phase II single arm, open-label clinical trial determining diagnostic accuracy of Flotufolastat F18 PET in subjects with prostate adenocarcinoma. These are subjects who have not previously received treatment for prostate cancer.

Who can participate

Age range18 Years

SexMALE

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Inclusion Criteria: * Age 18 years or greater at time of consent * Prostate adenocarcinoma (no other histologic subtypes allowed) * Prostate Cancer planned to be treated by focal therapy (e.g. cryotherapy, HIFU, or NanoKnife) * Multiparametric-MRI imaging planned * Planned pre- and post- treatment MRI-fusion biopsy Exclusion Criteria: * Prior treatment for any prostate malignancy (e.g. radiation, focal therapy, or systemic therapy) * Genomic classifiers (e.g. Decipher) signifying intermediate or high-risk disease * PSA \>10 * High-risk prostate cancer (diagnosed by biopsy) * Bilateral prostatic lobe disease

What they're measuring

Flotufolastat F18 PET findings

Timeframe: 5 years

Trial details

NCT IDNCT07568756

SponsorUniversity of California, Irvine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-05

Contact for this trial

Chao Family Comprehensive Cancer Center University of California, Irvine

1-877-827-8839 ucstudy@uci.edu

View on ClinicalTrials.gov More Prostate Adenocarcinoma trials