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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-90
SponsorJonsson Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men aged 18-90 at study enrollment

History of prostate cancer

Men who have had focal therapy (laser, cryotherapy, high-intensity focused ultrasound [HIFU], Tulsa Pro, irreversible electroporation [IRE], brachytherapy) within 6-36 months of enrollment

Disqualifiers

Contraindication to flotufolastat F 18 PET CT

Contraindication to ultrasound-guided prostate biopsy

Patients who are planned to have an x-ray contrast agent or other PET radiotracer < 24 hours prior to the PET scan

Patients with castrate levels of testosterone secondary to androgen deprivation therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Fluorine F 18 Flotufolastat

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Ultrasound-Guided Prostate Biopsy

    Procedure/Surgery

    Undergo PET/CT/ultrasound fusion biopsy

Treatment groups

81 Participants
are divided into 1 treatment group
Group A: Diagnostic (flotufolastat F-18 PET/CT)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Accuracy of fluorine F 18 flotufolastat (flotufolastat F 18) positron emission tomography (PET)/computed tomography (CT) in detecting residual or recurrent prostate cancer lesions

Time frame
Up to 10 years

Secondary outcomes

1

Optimal standardized uptake value (SUV) threshold of flotufolastat F 18 PET/CT

Will establish the optimal SUV threshold of flotufolastat F 18 PET/CT that correlates with the Gleason score obtained from prostate biopsies, establishing a quantitative imaging biomarker for assessing focal therapy success.

Time frame
Up to 10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jonsson Comprehensive Cancer Center

Lead sponsor

Blue Earth Diagnostics

Collaborator