RefleXion PET/CT Imaging Performance in Patients With Prostate Cancer

A Prospective Study of the RefleXion [18F]- DCFPyL PET-CT Subsystem Imaging Performance in Patients With Prostate Cancer

This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) [18F]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, [18F]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform [18F]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care [18F]-DCFPyL-PET-CT with the [18F]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Carcinoma
• Intervention / Treatment: Procedure: Computed Tomography; Other: Fluorine F 18 Piflufolastat; Device: Positron Emission Tomography

Detailed Description

PRIMARY OBJECTIVE:

I. To assess imaging performance of the fluorine F 18 piflufolastat ([18F]-DCFPyL) PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with prostate cancer.

SECONDARY OBJECTIVE:

I. To determine the feasibility of generating a biology-guided radiotherapy (BgRT) plan using X1 RMRS-acquired [18F]-DCFPyL PET data derived from the imaging-only session at the studied dose level.

OUTLINE:

Patients receive [18F]-DCFPyL intravenously (IV) and undergo [18F]-DCFPyL PET-CT over 30 minutes per standard of care (SOC). Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

After completion of study, patients are followed up within 72 hours.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented informed consent of the participant and/or legally authorized representative
• Age >= 21 years
• Patients undergoing SOC [18F]-DCFPyL PET-CT
• Patients should be scheduled for [18F]-DCFPyL PET-CT prior to study entry

Exclusion Criteria:

• Known psychiatric or substance abuse disorder that would interfere with conduct of the study
• Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT); Patients receive [18F]-DCFPyL IV and undergo [18F]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.

Procedure: Computed Tomography; Undergo PET/CT; Other Names: CT; CAT; CAT Scan; Computed Axial Tomography; Computerized Axial Tomography; Computerized Tomography; CT Scan; tomography; Other: Fluorine F 18 Piflufolastat; Given IV; Other Names: 18F-DCFPyL; Fluorine F 18 DCFPyL; Piflufolastat F 18; Piflufolastat F-18; Piflufolastat F18; Pylarify; Device: Positron Emission Tomography; Undergo PET/CT; Other Names: Medical Imaging, Positron Emission Tomography; PET; PET Scan; Positron Emission Tomography Scan; Positron-Emission Tomography; proton magnetic resonance spectroscopic imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of imaging performance of X1 RefleXion Medical Radiotherapy System (RMRS) positron emission tomography-computed tomography (PET-CT) with the diagnostic fluorine F 18 piflufolastat ([18F]-DCFPyL) PET-CT	For the standard of care (SOC) [18F]-DCFPyL PET-CT, the maximum standardized uptake value (SUV) and the greatest dimension in centimeters will be recorded for each PET avid malignant lesion identified by the nuclear medicine radiologist. The patient's radiation oncologist will interpret the X1 PET scan for the same metrics. Any discordances will be documented, and the final disposition recorded. Graphical presentations will be provided to compare SOC positive lesions and X1 positive lesions, and SOC positive lesions and X1 negative lesions with regards to lesion size, lesion location (bone, lymph nodes, soft tissue, visceral organ) and SUV uptake. Descriptive statistics will be utilized to quantify results. Mean, standard deviation, interquartile range (IQR), and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables. Statistical significance will be assessed at the 0.05 level, one-sided.	Up to 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of cases where X1 RMRS [18F]-DCFPyL PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan	The true positive lesions identified on the X1 PET images will be identified and used for BgRT planning. Simulated planning using the RefleXion treatment planning software will be performed, and the radiation dose to organs at risk calculated. Principal investigator will determine whether this plan is acceptable or not. The percent of cases in which RefleXion [18F]-DCFPyL PET data led to an acceptable plan will be recorded (descriptive statistics). Descriptive statistics will be utilized to quantify results. Mean, standard deviation, IQR, and range will be reported for each continuous variable. Frequency and percentage will be reported for categorical variables. Statistical significance will be assessed at the 0.05 level, one-sided.	Up to 72 hours

Collaborators and Investigators

• Sponsor: City of Hope Medical Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jeffrey Y Wong, City of Hope Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2022
• Primary Completion (Estimated): April 20, 2025
• Study Completion (Estimated): April 20, 2025

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: July 20, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: 22189 (Other Identifier: City of Hope Medical Center); P30CA033572 (U.S. NIH Grant/Contract); NCI-2022-05684 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes