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

April 28, 2026 updated by: Michael Daneshvar, University of California, Irvine
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chao Family Comprehensive Cancer Center University of California, Irvine
  • Phone Number: 1-877-827-8839
  • Email: ucstudy@uci.edu

Study Contact Backup

  • Name: University of California Irvine Medical Center

Study Locations

  • United States
    • California
      • Orange, California, United States, 92868
        • Chao Family Comprehensive Cancer Center, University of California, Irvine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Post-Focal Therapy Flotufolastat F18PET
Post-Focal Therapy Flotufolastat F18 PET
Diagnostic test: Flotufolastat F18 PET
Flotufolastat F18 PET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flotufolastat F18 PET findings
Time Frame: 5 years
Compare Flotufolastat F18 PET findings to mpMRI and MRI-fusion biopsy results to determine successful treatment by focal therapy.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Circulating Tumor Deoxyribonucleic acid (ctDNA) levels
Time Frame: 5 years
Changes between timepoints in circulating tumor deoxyribonucleic acid (ctDNA) from baseline (pre-therapy) to the defined post-therapy timepoint.
5 years
Changes in PSA levels
Time Frame: 5 years
Changes between timepoints in PSA from baseline (pre-therapy) to the defined post-therapy timepoint.
5 years
Change in genomic assay scores
Time Frame: 5 years
Change in genomic assay scores as measured using each assay's validated soring system from baseline (pre-therapy) to the defined post-therapy timepoint.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Blue Earth Diagnostics

Investigators

  • Principal Investigator: Michael Daneshvar, MD, Chao Family Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2028

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

April 28, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000746
  • UCI 25-100 (Other Identifier: UCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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