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Flotufolastat F18 PET for Prostate Cancer Evaluation After Focal Therapy

This study is looking at how well a diagnostic test called Flotufolastat F18 PET works in men with prostate cancer (prostate adenocarcinoma). These men have not had previous treatment for their prostate cancer and are planning to have a treatment called focal therapy (like cryotherapy, HIFU, or NanoKnife). The study will use the Flotufolastat F18 PET scan to see if it can accurately detect prostate cancer after focal therapy. We are looking for 60 men to participate. The main goal is to see the results of the Flotufolastat F18 PET scan after 5 years.

Study design
This is a Phase II, single-arm, open-label study involving 60 participants. It is designed to evaluate the diagnostic accuracy of Flotufolastat F18 PET.
What's involved
You would undergo Multiparametric-MRI imaging and planned pre- and post-treatment MRI-fusion biopsies. The study involves receiving a Flotufolastat F18 PET diagnostic test.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years to assess the Flotufolastat F18 PET findings.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07568756

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalDiagnostic
University of California, Irvine
~60 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Flotufolastat F18 PET

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Flotufolastat F18 PET findings
Measured over 5 years

Conditions

Prostate Adenocarcinoma
Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Michael Daneshvar, MD · PRINCIPAL_INVESTIGATOR · Chao Family Comprehensive Cancer Center

Who to contact

Chao Family Comprehensive Cancer Center University of California, Irvine
[email protected]
1-877-827-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Flotufolastat F18 PET findings5 years

    Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.