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18F-DCFPyL PET/CT Scan for Prostate Cancer

Phase 2

Waitlist Available

Led By Mohamad Allaf, MD

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

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

Must have

≥18 years of age

Clinical stage T1c-T2a on digital rectal exam

Must not have

Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to find prostate cancer that may be more accurate than current methods.

Who is the study for?

Men over 18 with a PSA level of 2-10 ng/mL, in the early clinical stages of prostate cancer (T1c-T2a), who are planning to undergo routine prostate biopsy and can give informed consent. Those who've recently had certain radiological procedures or contrast media, or have conditions that might interfere with the study, cannot participate.

What is being tested?

The trial is testing an injection called 18F-DCFPyL used during PET/CT scans to see how well it identifies significant prostate cancer compared to standard screening methods. It's a phase II study where participants receive this diagnostic agent before their scan.

What are the potential side effects?

As this trial focuses on a diagnostic imaging procedure using an injected tracer, side effects may include reactions at the injection site, potential allergic reactions to the tracer substance, and exposure to radiation from the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is in an early stage, as found by a physical exam.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I received an IV dye for an X-ray less than a day before my PET/CT scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biopsy

Secondary study objectives

Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions

Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI

Sensitivity of 18F-DCFPyL PET/CT relative to PSA