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18F-DCFPyL Imaging for Prostate Cancer

Phase 2
Recruiting
Led By Deborah E Citrin, 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
For individuals with a history of hepatitis C virus (HCV), the infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Must have at least 1 MRI detected, biopsy proven localized prostate cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence
Awards & highlights

Study Summary

This trial is testing an imaging agent to see if it can help detect response to prostate cancer treatment.

Who is the study for?
This trial is for men aged 18+ with newly diagnosed localized prostate cancer, planning to undergo SBRT possibly with ADT. They must have an ECOG status of <=2, use contraception if applicable, and can't have prior prostate cancer treatments. HIV-positive participants are eligible if virally suppressed.Check my eligibility
What is being tested?
Researchers are testing the effectiveness of a PET scan imaging agent called 18F-DCFPyL in detecting how well standard prostate cancer treatment works. Participants will undergo MRI and PET/CT scans before and after receiving SBRT (with or without ADT) to assess treatment response.See study design
What are the potential side effects?
Possible side effects include reactions to the contrast agent used during MRI (like allergic reactions), discomfort from lying still during scans, and typical risks associated with IV injections such as pain or infection at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My hepatitis C is cured or currently treated with no detectable virus.
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I have prostate cancer confirmed by MRI and biopsy.
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My hepatitis B virus load is undetectable with treatment.
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I have prostate cancer confirmed by biopsy and plan to undergo SBRT with or without hormone therapy.
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I am 18 years old or older.
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I am able to care for myself and perform daily activities.
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I have HIV but am on effective treatment with an undetectable viral load in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks after adt initiation (if applicable), 6 months post sbrt, at recurrence for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Imaging response to treatment

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: 18F-DCFPyL imagingExperimental Treatment1 Intervention
18F-DCFPyL imaging with routine imaging (mpMRI)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL
2019
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,627 Previous Clinical Trials
40,927,227 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,171 Patients Enrolled for Prostate Cancer
Deborah E Citrin, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
650 Total Patients Enrolled
5 Trials studying Prostate Cancer
438 Patients Enrolled for Prostate Cancer

Media Library

18F-DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT05155046 — Phase 2
Prostate Cancer Research Study Groups: 18F-DCFPyL imaging
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL Highlights & Side Effects. Trial Name: NCT05155046 — Phase 2
18F-DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT05155046 — Phase 2

Frequently Asked Questions

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

What applications is 18F-DCFPyL mainly employed for?

"18F-DCFPyL is commonly prescribed to patients with abnormally high serum prostate specific antigen (PSA) readings. This medication may also be beneficial for those suspected of having metastasis, undergoing positron emission tomography, or managing recurrent prostate cancer."

Answered by AI

Has 18F-DCFPyL been sanctioned by the FDA for use?

"18F-DCFPyL has been assigned a safety rating of 2, as it is currently undergoing Phase 2 trials. Although some preliminary information regarding its safety can be found, there are no reports on efficacy yet."

Answered by AI

How many participants are receiving treatment in this medical study?

"Indeed, the information on clinicaltrials.gov signposts that this trial is actively recruiting participants. It was initially posted on August 31st 2022 and has been recently updated October 15th 2022. This medical research requires 120 patients to be enrolled at a single location."

Answered by AI

Are there any openings for volunteers to participate in this trial?

"Affirmative. According to the clinicaltrials.gov records, this research is actively seeking participants after having been posted on August 31st 2022 and recently updated on October 15th 2022. The study requires 120 subjects from a single site for recruitment purposes."

Answered by AI

What empirical studies has 18F-DCFPyL been the focus of?

"At this time, 18F-DCFPyL is the subject of eighteen distinct clinical trials. None are in Phase 3 yet. Most studies for this medication take place in Baltimore, Maryland but there are 27 other locations where research is ongoing."

Answered by AI
~30 spots leftby Sep 2024