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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.
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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.
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My prostate cancer has been confirmed through a biopsy.
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I am willing to have a biopsy for research purposes.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy of DCFPyL-PET/CT diagnostics
Secondary outcome measures
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%
Fatigue
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-DCFPyL Injection

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
~350
18F-FDG
2010
Completed Phase 2
~660

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,636 Previous Clinical Trials
40,929,369 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,991 Patients Enrolled for Prostate Cancer
Peter L Choyke, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
435 Total Patients Enrolled
4 Trials studying Prostate Cancer
404 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

Frequently Asked Questions

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

Are there still opportunities for people to participate in this research?

"Unfortunately, this particular clinical trial is no longer looking for participants. The study began on June 6th 2017 and ended recruitment on November 8th 2022. For individuals interested in other prostate cancer trials, there are 3765 different studies enrolling patients. Additionally, if someone is specifically searching for 18F-DCFPyL trials, 35 are currently ongoing."

Answered by AI

How many people are joining this clinical trial?

"As of right now, this study has closed recruitment. The original posting date was June 6th, 2017 and the most recent update was November 8th, 2022. There are currently 3765 other trials looking for prostate cancer patients and 35 studies still enrolling 18F-DCFPyL participants."

Answered by AI

Has 18F-DCFPyL undergone FDA approval proceedings?

"18F-DCFPyL is a Phase 2 trial medication, so there is some data suggesting that it is safe but no information yet on whether or not it is effective."

Answered by AI

To the best of your knowledge, are there other research projects that have used 18F-DCFPyL?

"At the moment, there are 35 different clinical trials underway for 18F-DCFPyL. One of these trials is in Phase 3, while the rest are in earlier stages. Many of the studies for 18F-DCFPyL are based in Madison, Wisconsin, but there are 45 locations running clinical trials for 18F-DCFPyL across the country."

Answered by AI

What is 18F-DCFPyL used to treat most frequently?

"18F-DCFPyL is a radiopharmaceutical most often used in positron emission tomography (PET) scans. However, it can also be employed to treat prostate cancer and other conditions like altered osteogenesis."

Answered by AI
Recent research and studies
~35 spots leftby Dec 2025