NCT06580015

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

Recruiting now NA Last updated 18 July 2025

What this trial tests

NA trial testing Computed Tomography in Prostate Carcinoma in 20 participants. Currently enrolling.

Timeline

25 March 2025

Primary endpoint
9 January 2027

9 January 2027

Quick facts

Lead sponsor	City of Hope Medical Center
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	20
Start date	25 March 2025
Primary completion	9 January 2027
Estimated completion	9 January 2027
Sites	1 location across United States

Drugs / interventions tested

• Computed Tomography
• Flotufolastat F-18 Gallium (FLOTUFOLASTAT F-18 GALLIUM) — full drug profile →
• Medical Device Usage and Evaluation
• Positron Emission Tomography

Conditions studied

• Prostate Carcinoma — all drugs for Prostate Carcinoma →

Sponsor

City of Hope Medical Center

Who can join

21 and older, male only, with Prostate Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Prospective First-In-Human Pilot Study <sup>18</sup>F-DCFPyL Prostate-Specific Membrane Antigen Imaging on the RefleXion X1 Positron Emission Tomography-Computed Tomograpghy Subsystem in Patients with Prostate Cancer.
   Liu B, Dandapani S, Li Y, Glaser S, et al · · 2025 · PMID 41211608 · DOI 10.1016/j.adro.2025.101902