[18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer

NCT06580015 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-27

No results posted yet for this study

Summary

This clinical trial evaluates \[18F\]-rh PSMA positron emission tomography (PET)-computed tomography (CT) imaging performance in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA. Because some cancers take up \[18F\]-rhPSMA, cancer cells can be seen with PET. 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. Posluma (18F-rhPSMA) is an approved prostate-specific membrane antigen (PSMA) imaging agent for prostate cancer. The RefleXion Medical Radiotherapy System (RMRS) is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The system uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with fludeoxyglucose (FDG) (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiation therapy that will target (in real time) the signal released from the \[18F\]-rhPSMA PET-CT tracer. Comparing the imaging from the standard of care \[18F\]-rh PSMA PET-CT with the imaging from RMRS may help improve the quality of the imaging captured on the RMRS for detection of imaging signals in patients with prostate cancer.

Conditions

  • Prostate Carcinoma

Interventions

PROCEDURE

Computed Tomography

Undergo PET-CT

OTHER

Flotufolastat F-18 Gallium

Given IV

OTHER

Medical Device Usage and Evaluation

Undergo X1 RMRS PET-CT

PROCEDURE

Positron Emission Tomography

Undergo PET-CT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Jeffrey Y Wong, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-25
Primary Completion
2027-01-09
Completion
2027-01-09

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580015 on ClinicalTrials.gov