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PET/MRI with 18F-DCFPyL for Prostate Cancer

Phase 2
Waitlist Available
Led By Edward M Schaeffer, MD/PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must be age >= 18 years
Patients must have a positive screen for prostate cancer as confirmed by a prostate specific antigen (PSA) >= 2 ng/ml
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 days
Awards & highlights

Study Summary

This trial is testing how well PET/MRI works for diagnosing prostate cancer in men with an elevated PSA. 18F-DCFPyl is injected and it attaches to prostate cancer cells. A PET scan is then used to create images of how organs and tissues in the body are functioning.

Who is the study for?
Men with a PSA level of at least 2 ng/mL indicating potential prostate cancer, who are willing to undergo specific blood tests and biopsies as part of routine care. Participants must be over 18 years old and agree to use contraception for a day after imaging. Those with prior treatments, recent contrast medium use, past biopsies for prostate cancer, MRI contraindications like pacemakers, severely reduced kidney function or recent radioisotope administration cannot join.Check my eligibility
What is being tested?
The trial is testing the effectiveness of an imaging agent called 18F-DCFPyL in PET/MRI scans for diagnosing prostate cancer severity compared to multiparametric MRI alone. The study will assess how well this new method identifies tumor location and extent in men screened positive for prostate cancer.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radioactive imaging agent such as nausea or rash; discomfort from the biopsy procedure; allergic reactions to contrast agents used during MRI; and temporary side effects from the strong magnetic fields during MRI.

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 PSA level is 2 ng/ml or higher, indicating prostate cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy
Secondary outcome measures
Sensitivity of combined PET-mpMRI to mpMRI

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (18F-DCFPyL PET/MRI, mpMRI)Experimental Treatment7 Interventions
Patients receive fluorine F 18 DCFPyL IV and undergo PET/MRI. Patients also receive either gadobutrol IV or gadobenate dimeglumine IV (per radiologist preference), and undergo mpMRI. Within approximately 60 days after PET/MRI and mpMRI, patients undergo TRUS guided prostate biopsy per standard of care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Positron Emission Tomography
2008
Completed Phase 2
~2240
Gadobenate Dimeglumine
2020
Completed Phase 3
~130
Gadobutrol
2020
Completed Phase 3
~250
Magnetic Resonance Imaging
2017
Completed Phase 3
~1190

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,585 Previous Clinical Trials
917,125 Total Patients Enrolled
19 Trials studying Prostate Cancer
2,853 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,535 Total Patients Enrolled
560 Trials studying Prostate Cancer
507,067 Patients Enrolled for Prostate Cancer
Edward M Schaeffer, MD/PhDPrincipal InvestigatorNorthwestern University

Media Library

Fluorine F 18 DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT04910425 — Phase 2
Prostate Cancer Research Study Groups: Diagnostic (18F-DCFPyL PET/MRI, mpMRI)
Prostate Cancer Clinical Trial 2023: Fluorine F 18 DCFPyL Highlights & Side Effects. Trial Name: NCT04910425 — Phase 2
Fluorine F 18 DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT04910425 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there precedent studies involving Fluorine F 18 DCFPyL?

"There are a total of 28 ongoing clinical trials investigating the efficacy of Fluorine F 18 DCFPyL. 0% of these active studies are in Phase 3, which is promising. Though most of the research for this treatment is based out of Bethesda, Maryland, there are 97 locations running studies for this medication."

Answered by AI

Are new enrollees still being taken for this test program?

"Currently, this clinical trial is not looking for any more candidates. The original posting date was June 17th, 2023 and the most recent edit was on August 2nd, 2022. However, if you are exploring other studies, there are 1367 trials for prostate cancer and 28 trials for Fluorine F 18 DCFPyL that are still recruiting patients."

Answered by AI

What risks does Fluorine F 18 DCFPyL pose to study participants?

"Although there is some evidence that Fluorine F 18 DCFPyL is safe, as it is only a Phase 2 medication, more data surrounding its efficacy needs to be collected."

Answered by AI

How is Fluorine F 18 DCFPyL most commonly employed in patient care?

"Fluorine F 18 DCFPyL is the go-to treatment for suspected metastasis. However, this radioactive agent can also target other ailments like central nervous system disorders, positron emission tomography scanning, and prostate cancer."

Answered by AI

How many test subjects are part of this experiment?

"Unfortunately, this particular clinical trial is not recruiting at the moment. The study was first posted on 6/17/2023 but hasn't been updated in a while on 8/2/2022. However, there are plenty of other trials looking for patients right now- 1367 for prostate cancer and 28 for Fluorine F 18 DCFPyL."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer
2023. "PSMA-Targeted 18F-DCFPyL PET/MRI for the Detection of Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04910425.
~71 spots leftby Jun 2026
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