[18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer
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
3 other identifiers
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2024
CompletedFirst Posted
Study publicly available on registry
August 30, 2024
CompletedStudy Start
First participant enrolled
March 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 9, 2027
April 27, 2026
April 1, 2026
1.8 years
August 23, 2024
April 24, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS)
Will compare the performance of the \[18F\]-RhPSMA PET-CT subsystem on the RefleXion X1 system to detect selected lesions in patients with prostate cancer with the SOC diagnostic \[18F\]- RhPSMA PET-CT. One key metric will be the percent of patients with lesions identified on SOC PET-CT that are not identified on X1 (false negatives if considering SOC the true standard). With 25 patients with lesions detected by SOC Posluma PET who undergo X1 scanning, there is at least 93% chance of finding a false negative on X1 if the true false negative rate is 10%. With 25 patients, if there are no false negatives, a false negative rate of 11.3% or above can be ruled out with a type I error \<5%. Any discordances will be documented, and the final disposition recorded after a discussion between the radiation oncologist and the nuclear medicine radiologist. Graphical presentations will be provided to compare SOC positive lesions and X1 positive lesions, and SOC positive lesions and X1 neg
Up to 72 hours after completion of imagining session
Secondary Outcomes (2)
Incidence of change in treatment planning based on SOC Posluma
Up to 72 hours after imaging session
Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan
Up to 72 hours after imaging session
Study Arms (1)
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
EXPERIMENTALPatients 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.
Interventions
Undergo PET-CT
Given IV
Undergo X1 RMRS PET-CT
Undergo PET-CT
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- City of Hope Medical Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
City of Hope Medical Center
Duarte, California, 91010, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey Y Wong, MD
City of Hope Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2024
First Posted
August 30, 2024
Study Start
March 25, 2025
Primary Completion (Estimated)
January 9, 2027
Study Completion (Estimated)
January 9, 2027
Last Updated
April 27, 2026
Record last verified: 2026-04