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18F-DCFPyL PET/CT Imaging for Prostate Cancer

Phase 2 & 3
Waitlist Available
Research Sponsored by Sir Mortimer B. Davis - Jewish General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection
Must not have
Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new way to image prostate cancer in order to better understand how to treat it. Patients will receive an injection and then have a PET/CT scan. A panel of experts will review the images to see if they can better understand how to manage the disease.

Who is the study for?
Men over 18 with prostate cancer and signs of advanced disease, like bone pain or high PSA levels. They must be able to lie still for a PET/CT scan and fit within the machine's size limits. Those with severe claustrophobia, unstable health conditions, or who exceed the weight or size capacity for the PET/CT equipment cannot participate.
What is being tested?
The trial is testing how well an imaging drug called 18F-DCFPyL works in detecting prostate cancer spread when used during a PET/CT scan. The goal is to see if this method changes doctors' decisions about patient care compared to standard methods.
What are the potential side effects?
While not explicitly listed here, potential side effects may include reactions at the injection site, discomfort from lying still during scanning, and possible allergic reactions to the imaging agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can lie still for 40 minutes and handle an IV injection for a PET/CT scan.
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My prostate cancer has returned, shown by rising PSA levels above 0.1 ng/ml.
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I am male.
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I have been diagnosed with prostate cancer and am under a doctor's care.
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I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not currently experiencing any severe health crises like heart or breathing problems.
Select...
I weigh less than 400 lbs and can fit into a PET/CT scanner.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Differences in optimal clinical management
Secondary study objectives
Adverse events
Scan positivity fraction in BCR by PSA.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DCFPyL PET/CTExperimental Treatment1 Intervention
18F-DCFPyL PET/CT Scan
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL PET/CT
2017
Completed Phase 2
~120

Find a Location

Who is running the clinical trial?

Sir Mortimer B. Davis - Jewish General HospitalLead Sponsor
58 Previous Clinical Trials
19,716 Total Patients Enrolled
16 Trials studying Prostate Cancer
2,199 Patients Enrolled for Prostate Cancer

Media Library

Prostate Cancer Research Study Groups: 18F-DCFPyL PET/CT
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL PET/CT Highlights & Side Effects. Trial Name: NCT03459820 — Phase 2 & 3
18F-DCFPyL PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03459820 — Phase 2 & 3
~421 spots leftby Jun 2027
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