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An Investigational Scan (Flotufolastat F 18 PET/CT) for Detecting Residual or Recurrent Disease in Patients Who Completed Focal Therapy for Prostate Cancer.

NCT07185165 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2025-11-10

No results posted yet for this study

Summary

This phase II trial evaluates how well flotufolastat F 18 positron emission tomography (PET)/computed tomography (CT) imaging works to detect cancer that remains (residual) or that has come back (recurrent) after the completion of focal therapy for prostate cancer. Flotufolastat F 18 is a radioactive tracer that binds to prostate specific membrane antigen (PSMA), a protein over-expressed on prostate tumor cells. This allows for visualization of PSMA-expressing cells upon imaging. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of, in the case of this research, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes x-rays that track the body from the outside. CT images provide an exact outline of the organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. This device combines the anatomic (body structure) information provided by the CT scan with the metabolic information obtained from the PET scan. Metabolic information means how much of the injected tracer is taken up by inflammatory tissue. Flotufolastat F 18 PET/CT imaging may be an effective and less invasive way to detect residual or recurrent disease in prostate cancer patients, compared to other methods.

Conditions

  • Prostate Carcinoma

Interventions

PROCEDURE

Computed Tomography

Undergo PET/CT

DRUG

Fluorine F 18 Flotufolastat

Given IV

PROCEDURE

Positron Emission Tomography

Undergo PET/CT

PROCEDURE

Ultrasound-Guided Prostate Biopsy

Undergo PET/CT/ultrasound fusion biopsy

Sponsors & Collaborators

  • Blue Earth Diagnostics

    collaborator INDUSTRY

  • Jonsson Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Wayne Brisbane · UCLA / Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-09
Primary Completion
2035-10-25
Completion
2036-10-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07185165 on ClinicalTrials.gov