Posluma (18F-rhPSMA) PET Guided Radiotherapy Planning in Prostate Cancer: A Prospective Study Evaluating POSLUMA PET Tumor Detection on Radiation Therapy Planning and on BGRT Planning on the RefleXion X1 System

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 21
Healthy Volunteers: f
View:

• Documented informed consent of the participant and/or legally authorized representative

• Age: ≥ 21 years

• Patients with SOC \[18F\]-RhPSMA PET-CT in whom a PET avid lesion is identified

• Able to get same day X1 RMRS PET

Locations
United States
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Jeffrey Wong, MD
jwong@coh.org
626-359-8111
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2027-01-09
Participants
Target number of participants: 20
Treatments
Experimental: Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov

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