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

Conditions

• Prostate Carcinoma

Eligibility Criteria

Sex

MALE

Age

18 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Computed Tomography — PROCEDURE
  Undergo PET/CT
• Fluorine F 18 Flotufolastat — DRUG
  Given IV
• Positron Emission Tomography — PROCEDURE
  Undergo PET/CT
• Ultrasound-Guided Prostate Biopsy — PROCEDURE
  Undergo PET/CT/ultrasound fusion biopsy

Study Details

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.

Key Dates

Start date

Oct 9, 2025

Status verified

Sep 2025

Primary completion

Oct 25, 2035

Completion

Oct 25, 2036

Study Design

Enrollment

81 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

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.

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

• Kyla Grunden
  310-206-7576
  [email protected]

Locations (1)

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