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18F-DCFPyL PET/CT Imaging for Prostate Cancer

Phase 2

Waitlist Available

Led By Peter L Choyke, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Patients fit criteria for one of the following categories: Cohort 1 known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging, OR Cohort 2 nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL

Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2

Must not have

Subjects with severe claustrophobia unresponsive to oral anxiolytics

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the radiotracer 18F-DCFPyL can help identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.

Who is the study for?

Men 18+ with prostate cancer either newly diagnosed as high risk or showing signs of recurrence after treatment. They must be able to consent, agree to use contraception, and fit within the scanner's weight limit. Exclusions include severe claustrophobia, conditions that could affect results, excessive serum creatinine levels, or if participation delays standard care.

What is being tested?

The trial is testing a radiotracer called 18F-DCFPyL for detecting prostate cancer in high-risk or recurrent cases. Participants will undergo scans using this tracer and may have additional MRI scans and biopsies. The study aims to improve imaging techniques for better diagnosis and management of prostate cancer.

What are the potential side effects?

While specific side effects are not listed for the radiotracer 18F-DCFPyL itself, general risks may include allergic reactions to the tracer substance, discomfort from IV insertion for tracer administration, potential side effects from contrast agents used during MRI scans like nausea or headache.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My prostate cancer was confirmed through a tissue examination.

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I am willing to have a biopsy for research purposes.

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I am 18 years old or older.

Exclusion Criteria

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

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I have severe claustrophobia that doesn't improve with anxiety medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer

Secondary study objectives

Compare focal 18F-DCFPyL uptake with focal abnormalities identified on standard of care imaging

Compare the distribution of 18F-DCFPyL uptake with multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy

Evaluate the distribution of 18F-DCFPyL uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown) as a function of PSA value