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PET/CT Imaging for Prostate Cancer

N/A

Waitlist Available

Led By Jeffrey Y Wong

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether the RefleXion Medical Radiotherapy System (RMRS) can be used to image prostate cancer as well as the standard of care ([18F]-DCFPyL positron emission tomography-computed tomography (PET-CT)).

Who is the study for?

This trial is for adults over 21 with prostate cancer who are scheduled to undergo standard PET-CT imaging using a tracer that targets tumor cells. It's not suitable for individuals exceeding 450 pounds or those with psychiatric/substance abuse issues that could affect study participation.

What is being tested?

The study compares the performance of RefleXion Medical Radiotherapy System (RMRS) imaging against standard PET-CT in detecting prostate cancer. The goal is to see if RMRS can improve image quality and combine scan planning with radiation therapy, potentially reducing the number of scans needed.

What are the potential side effects?

Since this trial focuses on imaging techniques rather than medication, typical side effects associated with drugs aren't expected. However, exposure to radiation from PET-CT scans carries a minimal risk of long-term radiation effects.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 72 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 72 hours

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

Treatment Details

Study Objectives

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

Primary study objectives

Positron-Emission Tomography

Secondary study objectives

Percent of cases where X1 RMRS [18F]-DCFPyL 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: Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)Experimental Treatment3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Positron Emission Tomography

2011

Completed Phase 2

~2200

Computed Tomography

2017

Completed Phase 2

~2790