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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

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

Headache

Fatigue

Hypertension

100%

80%

60%

40%

20%

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,662 Previous Clinical Trials

40,925,701 Total Patients Enrolled

560 Trials studying Prostate Cancer

506,915 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

Journal of Nuclear MedicineJournal

Biodistribution, Tumor Detection, and Radiation Dosimetry of <sup>18</sup>f-dcfbc, a Low-molecular-weight Inhibitor of Prostate-specific Membrane Antigen, in Patients with Metastatic Prostate Cancer

Cho, Steve Y., Kenneth L. Gage, Ronnie C. Mease, Srinivasan Senthamizhchelvan, Daniel P. Holt, Akimosa Jeffrey-Kwanisai, Christopher J. Endres, et al.. 2012. “Biodistribution, Tumor Detection, and Radiation Dosimetry of 18f-dcfbc, a Low-molecular-weight Inhibitor of Prostate-specific Membrane Antigen, in Patients with Metastatic Prostate Cancer”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.112.104661.

Clinical Cancer ResearchJournal

2-(3-{1-carboxy-5-[(6-[18f]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic Acid, [18f]dcfpyl, a Psma-based PET Imaging Agent for Prostate Cancer

Chen, Ying, Mrudula Pullambhatla, Catherine A. Foss, Youngjoo Byun, Sridhar Nimmagadda, Srinivasan Senthamizhchelvan, George Sgouros, Ronnie C. Mease, and Martin G. Pomper. 2011. “2-(3-{1-carboxy-5-[(6-[18f]fluoro-pyridine-3-carbonyl)-amino]-pentyl}-ureido)-pentanedioic Acid, [18f]dcfpyl, a Psma-based PET Imaging Agent for Prostate Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-11-1357.

Molecular Imaging and BiologyJournal

Initial Evaluation of [18f]dcfpyl for Prostate-specific Membrane Antigen (psma)-targeted PET Imaging of Prostate Cancer

Szabo, Zsolt, Esther Mena, Steven P. Rowe, Donika Plyku, Rosa Nidal, Mario A. Eisenberger, Emmanuel S. Antonarakis, et al.. 2015. “Initial Evaluation of [18f]dcfpyl for Prostate-specific Membrane Antigen (psma)-targeted PET Imaging of Prostate Cancer”. Molecular Imaging and Biology. Springer Science and Business Media LLC. doi:10.1007/s11307-015-0850-8.

clinicaltrials.govStudy