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18F-DCFPyL PET/CT Scan for Prostate Cancer

Phase 2
Waitlist Available
Led By Mohamad Allaf, MD
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
≥18 years of age
Clinical stage T1c-T2a on digital rectal exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 years
Awards & highlights

Study Summary

This trial is testing a new way to find prostate cancer that may be more accurate than current methods.

Who is the study for?
Men over 18 with a PSA level of 2-10 ng/mL, in the early clinical stages of prostate cancer (T1c-T2a), who are planning to undergo routine prostate biopsy and can give informed consent. Those who've recently had certain radiological procedures or contrast media, or have conditions that might interfere with the study, cannot participate.Check my eligibility
What is being tested?
The trial is testing an injection called 18F-DCFPyL used during PET/CT scans to see how well it identifies significant prostate cancer compared to standard screening methods. It's a phase II study where participants receive this diagnostic agent before their scan.See study design
What are the potential side effects?
As this trial focuses on a diagnostic imaging procedure using an injected tracer, side effects may include reactions at the injection site, potential allergic reactions to the tracer substance, and exposure to radiation from the PET/CT scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My cancer is in an early stage, as found by a physical exam.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Biopsy
Secondary outcome measures
Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions
Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI
Sensitivity of 18F-DCFPyL PET/CT relative to PSA

Side effects data

From 2018 Phase 2 & 3 trial • 385 Patients • NCT02981368
1%
atrial fibrillation
1%
pyelonephritis, acute
1%
hyperkalaemia
1%
spinal cord compression
1%
coronary artery disease
1%
Lower gastrointestinal haemmorhage
1%
dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recurrent or Metastatic Prostate Cancer (Cohort B)
High Risk Prostate Cancer (Cohort A)

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DCFPyL InjectionExperimental Treatment1 Intervention
A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL Injection
2015
Completed Phase 3
~480

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
555 Previous Clinical Trials
32,763 Total Patients Enrolled
56 Trials studying Prostate Cancer
3,198 Patients Enrolled for Prostate Cancer
Progenics Pharmaceuticals, Inc.Industry Sponsor
32 Previous Clinical Trials
4,790 Total Patients Enrolled
17 Trials studying Prostate Cancer
2,184 Patients Enrolled for Prostate Cancer
Mohamad Allaf, MDPrincipal InvestigatorJohns Hopkins University
2 Previous Clinical Trials
159 Total Patients Enrolled

Media Library

18F-DCFPyL Injection Clinical Trial Eligibility Overview. Trial Name: NCT03471650 — Phase 2
Prostate Cancer Research Study Groups: 18F-DCFPyL Injection
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL Injection Highlights & Side Effects. Trial Name: NCT03471650 — Phase 2
18F-DCFPyL Injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT03471650 — Phase 2

Frequently Asked Questions

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

How many participants are being welcomed into this clinical trial?

"This trial is currently not accepting new patients, as the final edit was made on April 5th 2022. However, if you are looking for other studies related to prostate cancer, 1,321 trials have opened their doors to participants and 18 such trials concern 18F-DCFPyL Injection."

Answered by AI

To what degree is 18F-DCFPyL Injection a risk to human health and wellbeing?

"According to our team's assessment, 18F-DCFPyL Injection scored a 2 on the safety scale since there is some evidence of its security but none detailing any efficacy."

Answered by AI

Could you elucidate on other experiments that have utilized 18F-DCFPyL Injection?

"Currently, there are 18 studies ongoing researching the efficacy of 18F-DCFPyL Injection with none in Phase 3. Primarily based out of Baltimore, Maryland; however, a total of 27 locations across the nation are conducting research for this drug."

Answered by AI

What therapeutic applications is 18F-DCFPyL Injection being applied to?

"18F-DCFPyL Injection is commonly utilized for the management of elevated serum prostate specific antigen (psa). It can also benefit those affected by suspected metastasis, positron emission tomography imaging, and recurrent prostatic carcinoma."

Answered by AI

Is there opportunity for new participants in this investigation?

"The details published on clinicaltrials.gov confirm that this research is not recruiting participants at present, with the initial posting taking place on March 29th 2018 and the most recent update being April 5th 2022. Nevertheless, there are over 1300 other medical studies which currently have open enrollment options available."

Answered by AI
~20 spots leftby Mar 2025