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

NCT07185165 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 24-1371NCI-2025-06280
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Outcome Measures

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

  Up to 10 years

Secondary Outcomes (1)

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

  Up to 10 years

Study Arms (1)

Diagnostic (flotufolastat F-18 PET/CT)

EXPERIMENTAL

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.

Procedure: Computed Tomography; Drug: Fluorine F 18 Flotufolastat; Procedure: Positron Emission Tomography; Procedure: Ultrasound-Guided Prostate Biopsy

Interventions

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography

Diagnostic (flotufolastat F-18 PET/CT)

Fluorine F 18 Flotufolastat DRUG

Given IV

Also known as: FLOTUFOLASTAT F-18, RHPSMA-7.3C

Diagnostic (flotufolastat F-18 PET/CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Diagnostic (flotufolastat F-18 PET/CT)

Ultrasound-Guided Prostate Biopsy PROCEDURE

Undergo PET/CT/ultrasound fusion biopsy

Diagnostic (flotufolastat F-18 PET/CT)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Blue Earth Diagnostics: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Wayne Brisbane

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyla Grunden

CONTACT

310-206-7576; kgrunden@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 22, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): October 25, 2035
• Study Completion (Estimated): October 25, 2036
• Last Updated: November 10, 2025

Record last verified: 2025-09

Locations

US (1)