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PET-CT Imaging for Prostate Cancer

N/A

Waitlist Available

Led By Jeffrey Y Wong, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: ≥ 21 years

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours after imaging session

Awards & highlights

No Placebo-Only Group

Summary

This trial evaluates a new imaging technique using a radioactive tracer called \[18F\]-rh PSMA in patients with prostate cancer. The technique combines positron emission tomography (PET) and computed

Who is the study for?

This trial is for adults over 21 with prostate cancer who have already had a standard PET-CT scan showing active cancer spots. They must be able to undergo an additional RMRS PET scan on the same day and provide informed consent.

What is being tested?

The study tests how well a new type of PET-CT imaging using [18F]-rhPSMA works compared to the current method. It's part of research to improve real-time, targeted radiation therapy planning and delivery in prostate cancer treatment.

What are the potential side effects?

Since this trial focuses on imaging performance rather than drug effects, side effects are minimal but may include discomfort from lying still during scans or reactions to tracers used in PET-CT imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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My PET scan shows active cancer spots.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 hours after imaging session

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 hours after imaging session

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours after imaging session for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS)

Secondary study objectives

Incidence of change in treatment planning based on SOC Posluma

Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)Experimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Computed Tomography

2017

Completed Phase 2

~2740

Positron Emission Tomography

2011

Completed Phase 2

~2200