Recruiting
Phase 2

Flotufolastat F 18

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT07185165

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Computed Tomography

Fluorine F 18 Flotufolastat

Positron Emission Tomography

Ultrasound-Guided Prostate Biopsy

Study Details

Brief 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

Study ID

NCT07185165

Start date

Oct 9, 2025

Status verified date

Sep, 2025

Completion date

Oct 25, 2036

Anticipated

Primary completion date

Oct 25, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Inability to provide written informed consent
  • Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
  • Any investigational agents within 42 days prior to the day of the first dose
  • Not able to understand and to follow study instructions and requirements. This also includes the inability to complete the study imaging and or biopsy procedures due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time, any condition that precludes raised arms position)

Study Design

Enrollment

81 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Diagnostic (flotufolastat F-18 PET/CT)

Patients receive flotufolastat F-18 IV. Then 50-100 minutes after injection, patients undergo whole-body PET/CT over 20-50 minutes. Patients then undergo PET/CT/ultrasound fusion biopsy within 3 months.

Interventions

Computed Tomography

Undergo PET/CT

Fluorine F 18 Flotufolastat

Given IV

Positron Emission Tomography

Undergo PET/CT

Ultrasound-Guided Prostate Biopsy

Undergo PET/CT/ultrasound fusion biopsy

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Wayne Brisbane

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Nov 10, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2025-11-10.