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18F-DCFPyL PET/CT Imaging 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 fit criteria for one of the following categories: Cohort 1 known localized high risk prostate cancer (PSA >10, Gleason 8-10 or clinical stage >T2c) with evidence of disease on standard imaging, OR Cohort 2 nonspecific or no evidence of disease on standard imaging modality AND biochemical prostate cancer relapse with a PSA greater than or equal to 0.2 ng/mL
Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights
Study Summary
This trial is testing whether the radiotracer 18F-DCFPyL can help identify prostate cancer in patients who have a high risk of cancer spreading outside the prostate or who have signs of recurrent cancer after treatment.
Who is the study for?
Men 18+ with prostate cancer either newly diagnosed as high risk or showing signs of recurrence after treatment. They must be able to consent, agree to use contraception, and fit within the scanner's weight limit. Exclusions include severe claustrophobia, conditions that could affect results, excessive serum creatinine levels, or if participation delays standard care.Check my eligibility
What is being tested?
The trial is testing a radiotracer called 18F-DCFPyL for detecting prostate cancer in high-risk or recurrent cases. Participants will undergo scans using this tracer and may have additional MRI scans and biopsies. The study aims to improve imaging techniques for better diagnosis and management of prostate cancer.See study design
What are the potential side effects?
While specific side effects are not listed for the radiotracer 18F-DCFPyL itself, general risks may include allergic reactions to the tracer substance, discomfort from IV insertion for tracer administration, potential side effects from contrast agents used during MRI scans like nausea or headache.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
My prostate cancer was confirmed through a tissue examination.
Select...
I am willing to have a biopsy for research purposes.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To assess the ability of 18F-DCFPyL to accurately stage high-risk primary prostate cancer and detect sites of recurrent prostate cancer
Secondary outcome measures
Compare focal 18F-DCFPyL uptake with focal abnormalities identified on standard of care imaging
Compare the distribution of 18F-DCFPyL uptake with multiparametric MRI and whole mount histopathology in patients undergoing prostatectomy
Evaluate the distribution of 18F-DCFPyL uptake in prostate cancer patients with biochemical relapse (site of recurrence unknown) as a function of PSA value
Side effects data
From 2019 Phase 3 trial • 208 Patients • NCT037396841%
Headache
1%
Fatigue
1%
Hypertension
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-DCFPyL Injection
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2/biochemical recurrence (bcr)Experimental Treatment3 Interventions
18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional)
Group II: 1/Localized High RiskExperimental Treatment2 Interventions
18F-DCFPyL PET/CT imaging, unlabeled PSMA-11 (optional) and possible prostatectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
13,660 Previous Clinical Trials
40,923,942 Total Patients Enrolled
560 Trials studying Prostate Cancer
506,765 Patients Enrolled for Prostate Cancer
Peter L Choyke, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
285 Total Patients Enrolled
4 Trials studying Prostate Cancer
254 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during and for 2 months after the study.I have severe claustrophobia that doesn't improve with anxiety medication.I can take care of myself and am up and about more than half of my waking hours.My prostate cancer was confirmed through a tissue examination.Joining this trial won't delay my usual cancer treatment.I am willing to have a biopsy for research purposes.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 2/biochemical recurrence (bcr)
- Group 2: 1/Localized High Risk
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are we able to enroll new participants in this research program at this time?
"The clinical trial in question is not currently looking for new patients, as seen on clinicaltrials.gov. This specific study was originally posted on August 3rd, 2017 and updated last on October 4th, 2022. There are however, 1409 other trials that are recruiting patients right now."
Answered by AI
How is 18F-DCFPyL primarily employed?
"18F-DCFPyL is a versatile medical intervention that can be used for positron emission tomography, as well as treating prostate cancer, left ventricular dysfunction, seizures and epileptic conditions."
Answered by AI
To your knowledge, are there other ongoing research trials that use 18F-DCFPyL?
"Out of the 35 ongoing studies investigating 18F-DCFPyL, 1 is currently in Phase 3. Most research concerning this topic takes place in Baltimore, although 45 different locations are running trials for this treatment."
Answered by AI
Are there any dangers associated with 18F-DCFPyL?
"There is some evidence of 18F-DCFPyL's safety, but none to support efficacy, so it was given a score of 2."
Answered by AI
How many people are being recruited for this clinical trial?
"This clinical trial is not recruiting at this time. The study was first posted on August 3, 2017 and updated October 4, 2022. There are 1374 other studies for patients with prostate cancer and 35 for 18F-DCFPyL currently admitting participants."
Answered by AI
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