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PET Imaging Tracers 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 must have confirmation of prostate cancer with identifiable metastatic disease on at least 1 clinically indicated imaging modality. If there is only soft tissue metastasis, one lesion must measure at least 6 mm or greater OR Documented history of metastatic prostate cancer
Age greater than or equal to 18 years old
Must not have
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new radiotracer called 18F-DCFPyL to see if it can help identify sites of prostate cancer in people with the disease.

Who is the study for?
This trial is for adults over 18 with metastatic prostate cancer, who can undergo a biopsy and have an ECOG score of 0-2. They must be enrolled in certain other protocols, understand the consent form, and not exceed weight limits for imaging equipment. Those with severe claustrophobia or conditions that conflict with study procedures are excluded.
What is being tested?
The trial tests if a new radiotracer called 18F-DCFPyL can better detect prostate cancer compared to standard tracers (18F-NaF). Participants will receive injections of these tracers before undergoing PET/CT scans to see which provides clearer images of cancer sites.
What are the potential side effects?
Potential side effects may include reactions at the injection site, discomfort from lying still during scans, anxiety related to claustrophobia during imaging procedures, and risks associated with biopsies such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prostate cancer that has spread, confirmed by scans.
Select...
I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
Select...
My prostate cancer has been confirmed through a biopsy.
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I am willing to have a biopsy for research purposes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe claustrophobia that doesn't improve with anxiety medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Accuracy of DCFPyL-PET/CT diagnostics
Secondary study objectives
Association between PSA parameters and the number of metastases identified with DCFPyL- PET/CT (or PET/MRI imaging if available).
PSMA expression in lesion samples from patients with presumed stable disease and actively expanding disease

Side effects data

From 2019 Phase 3 trial • 208 Patients • NCT03739684
1%
Headache
1%
Hypertension
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-DCFPyL Injection

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: 1/Experimental interventionExperimental Treatment3 Interventions
18F-DCFPyL is administered to cohorts
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-NaF
2016
Completed Phase 1
~30
18F-DCFPyL
2019
Completed Phase 3
~600
18F-FDG
2017
Completed Phase 4
~750

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,938 Previous Clinical Trials
41,023,092 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,864 Patients Enrolled for Prostate Cancer
Peter L Choyke, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
905 Total Patients Enrolled
4 Trials studying Prostate Cancer
874 Patients Enrolled for Prostate Cancer

Media Library

18F-DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT03173924 — Phase 2
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL Highlights & Side Effects. Trial Name: NCT03173924 — Phase 2
18F-DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT03173924 — Phase 2
~28 spots leftby Feb 2028
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