Prostate Carcinoma
Conditions
Brief summary
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.
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
Given IV
DEVICEPositron Emission Tomography
Undergo PET/CT
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT) | Up to 72 hours after completion of scan | To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan | Up to 72 hours | 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. |
Countries
United States
Participant flow
Recruitment details
A total of 34 patients provided informed consent.
Participants by arm
| Arm | Count |
|---|---|
| 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.
Computed Tomography: Undergo PET/CT
Fluorine F 18 Piflufolastat: Given IV
Positron Emission Tomography: Undergo PET/CT | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not receive intervention | 13 |
| Overall Study | Ineligible | 1 |
Baseline characteristics
| Characteristic | Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) |
|---|---|
| Age, Continuous | 72 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)
To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.
Time frame: Up to 72 hours after completion of scan
Population: Biology-guided radiotherapy plans were successfully generated for 18 patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) | Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT) | 1 Participants |
Secondary
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.
Time frame: Up to 72 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT) | Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan | 18 Participants |