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18F-DCFPyL Imaging for Prostate Cancer

Phase < 1

Waitlist Available

Led By Steve Y Cho, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

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

Must have

Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores

Be older than 18 years old

Must not have

Androgen deprivation therapy for prostate cancer

Chemotherapy for prostate cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one study visit (up to 3.5 hours)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a new imaging technique can detect prostate cancer and distinguish between different types of the disease.

Who is the study for?

This trial is for men with prostate cancer, who may have metastatic disease and are fit for a prostatectomy. It includes those newly diagnosed or undergoing biopsy evaluation, with no recent chemotherapy or investigational therapy. Participants should not have had prior pelvic radiation and must be able to undergo PET/CT scans.

What is being tested?

The study tests the effectiveness of a new imaging biomarker called 18F-DCFPyL PET in detecting, tracking progression, and recurrence of prostate cancer. The goal is to distinguish between aggressive and indolent cancer types to tailor treatment plans.

What are the potential side effects?

As this trial focuses on an imaging technique rather than a drug intervention, side effects are minimal but may include discomfort from lying flat during the scan or reactions related to contrast agents used.

Eligibility Criteria

Inclusion Criteria

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

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My prostate cancer biopsy shows a Gleason score of 6 or higher with more than 2 positive cores.

Exclusion Criteria

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

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I am receiving hormone therapy for prostate cancer.

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I am receiving chemotherapy for prostate cancer.

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I have had radiation therapy to my pelvis before.

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I cannot lie flat for scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one study visit (up to 3.5 hours)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one study visit (up to 3.5 hours)

This trial's timeline: 3 weeks for screening, Varies for treatment, and one study visit (up to 3.5 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

Malignant Neoplasms

Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence

+1 more

Secondary study objectives

Magnetic Resonance Imaging

Sub-Study 1: Low-dose CT versus MRI derived PET SUV

Sub-Study 1: Specificity of 18F-DCFPyL

+12 more

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: 18F-DCFPyL PETExperimental Treatment1 Intervention

Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

18F-DCFPyL PET

2017

Completed Early Phase 1

~130

0 / 5Eligibility criteria met