Prostate CarcinomaNCT06580015
[18F]-rhPSMA PET-CT Imaging Performance in Patients With Prostate Cancer
A study testing Computed Tomography, Flotufolastat F-18 Gallium and Medical Device Usage and Evaluation in people with Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Computed Tomography, Flotufolastat F-18 Gallium and Medical Device Usage and Evaluation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2025to 9 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: 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
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the imaging performance of flotufolastat F-18 gallium ([18F]-rhPSMA) PET-CT imaging subsystem of the RefleXion Medical Radiotherapy System Device in patients with lesions detected on standard-of-care (SOC) [18F]-rhPSMA PET-CT on the same day.
SECONDARY OBJECTIVES:
- To evaluate the frequency that SOC Posluma imaging will result in the ability to distinctly identify and separate PET activity from bladder activity to aid in the detection, lesion contouring, RT planning and RT delivery for intra-prostatic lesions, prostate bed lesions (salvage RT) or lesions near the bladder.
II. To evaluate the frequency that SOC Posluma imaging will result in a change in radiotherapy planning through either exclusion due to extra-pelvic metastatic disease or detection of disease that results in a modification of RT field coverage or dose.
III. Evaluate the potential for using the X1 RMRS PET used to generate an acceptable BgRT plan such that dosimetric parameters for the target and the nearby normal anatomy are met based on investigator assessment.
OUTLINE:
Patients receive SOC flotufolastat F-18 gallium intravenously (IV) and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
After completion of study intervention, patients are followed up within 72 hours of PET imaging-only session.
- Conditions
- Prostate Carcinoma
- Being tested
- Computed Tomography, Flotufolastat F-18 Gallium, Medical Device Usage and Evaluation, Positron Emission Tomography
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo PET-CT
Flotufolastat F-18 GalliumOther
Also called (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3
Given IV
Medical Device Usage and EvaluationOther
Undergo X1 RMRS PET-CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET-CT
| Study group | Role | What they receive |
|---|---|---|
| Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT) | Experimental | 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. Receives: Procedure: Computed Tomography; Other: Flotufolastat F-18 Gallium; Other: Medical Device Usage and Evaluation; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 72 hours after completion of imagining session
Secondary outcomes (2)
Incidence of change in treatment planning based on SOC Posluma
Will be assessed in a descriptive manner.
Measured: 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
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]-RhPSMAcPET 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.
Measured: Up to 72 hours after imaging session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start25 Mar 2025
- Primary completion9 Jan 2027 (estimated)
- Study completion9 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Y Wong, MD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580015
- Sponsor's protocol ID
- 24163
- Other IDs
- NCI-2024-06849, 24163, P30CA033572
- Status last verified
- Apr 2026
- First submitted
- 23 Aug 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06580015
- Acronym / sponsor ID
- 24163
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 9 Jan 2027 (estimated)
- Study completion
- 9 Jan 2027 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the imaging performance of flotufolastat F-18 gallium ([18F]-rhPSMA) PET-CT imaging subsystem of the RefleXion Medical Radiotherapy System Device in patients with lesions detected on standard-of-care (SOC) [18F]-rhPSMA PET-CT on the same day.
SECONDARY OBJECTIVES:
- To evaluate the frequency that SOC Posluma imaging will result in the ability to distinctly identify and separate PET activity from bladder activity to aid in the detection, lesion contouring, RT planning and RT delivery for intra-prostatic lesions, prostate bed lesions (salvage RT) or lesions near the bladder.
II. To evaluate the frequency that SOC Posluma imaging will result in a change in radiotherapy planning through either exclusion due to extra-pelvic metastatic disease or detection of disease that results in a modification of RT field coverage or dose.
III. Evaluate the potential for using the X1 RMRS PET used to generate an acceptable BgRT plan such that dosimetric parameters for the target and the nearby normal anatomy are met based on investigator assessment.
OUTLINE:
Patients receive SOC flotufolastat F-18 gallium intravenously (IV) and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
After completion of study intervention, patients are followed up within 72 hours of PET imaging-only session.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT) | Experimental | Procedure: Computed Tomography, Other: Flotufolastat F-18 Gallium, Other: Medical Device Usage and Evaluation, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo PET-CT | Procedure or surgery | Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT) |
| Flotufolastat F-18 GalliumAlso: (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3Given IV | Other | Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT) |
| Medical Device Usage and EvaluationUndergo X1 RMRS PET-CT | Other | Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET-CT | Procedure or surgery | Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT) |
Primary outcome
Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS)
Time frame: Up to 72 hours after completion of imagining session
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
2 secondary outcomes
Incidence of change in treatment planning based on SOC Posluma
Time frame: 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
Time frame: Up to 72 hours after imaging session
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Y Wong, MD principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computed Tomography, Flotufolastat F-18 Gallium and Medical Device Usage and Evaluation in people with Prostate Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS) (time frame: Up to 72 hours after completion of imagining session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.