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PSMA-Based PET Imaging for Prostate Cancer

Phase 2
Waitlist Available
Led By William L Dahut, 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
Men age greater than or equal to 18 years.
Patients must be eligible for and must be planning to undergo radical prostatectomy and lymphadenectomy regardless of findings on 18F-DCFPyL PET/CT
Must not have
Contraindication to MRI or PET: Patients weighing more than weight limit for the scanner tables or unable to fit within the imaging gantry, Prior reaction to 18F-DCFPyL, Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic device that are not MRI compatible at 3 T, Severe claustrophobia unresponsive to oral anxiolytics, Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements, Other medical conditions deemed by the principal investigator (or associates) to make the subject unsafe/ineligible for the protocol procedures or for radical prostatectomy, A malignancy within the past 3 years for which prostatectomy is a contraindication, Radiotracer administered within 5 half-lives prior to the date of 18F-DCFPyL PET/CT imaging, PSMA-targeted imaging within 6 months with 18F-DCFPyL tracer prior to the date of 18F-DCFPyL PET/CT imaging. Participants can have PSMA targeted imaging with Gallium, Unable to refrain from fathering a child or donating sperm for 10 days after each 18FDCFPyL injection.
Any prior therapy for prostate cancer with surgery, radiation, and/or chemotherapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a PET/CT scan can help doctors better predict if prostate cancer will return after surgery.

Who is the study for?
Men over 18 with high-risk prostate cancer that's likely still in the prostate but could have spread. They must be healthy enough for surgery, able to undergo certain scans and biopsies if needed, and not have had any prior treatments or other cancers within 3 years.
What is being tested?
The trial is testing a new PET/CT scan using the tracer 18F-DCFPyL before removing the prostate gland to see if it can predict cancer recurrence better than current methods. Participants will be followed up for five years after surgery.
What are the potential side effects?
Potential side effects from the radiotracer injection may include allergic reactions or discomfort at the injection site. The PET/CT scan itself is generally safe but may cause anxiety or discomfort due to lying still.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a man aged 18 or older.
Select...
I am planning to have surgery to remove my prostate and lymph nodes.
Select...
My blood and organ functions are within the required ranges.
Select...
My prostate cancer is high risk with a Gleason score of 8 or higher, PSA over 20, or it has spread beyond the prostate.
Select...
My prostate cancer diagnosis was confirmed by a certified lab.
Select...
I can do most of my daily activities without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had treatment for prostate cancer, including surgery, radiation, or chemotherapy.
Select...
My cancer has spread to nearby areas but not the seminal vesicles.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 3,6,9,12, and 18 months, 2,3, and 4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
progression free survival

Side effects data

From 2019 Phase 3 trial • 208 Patients • NCT03739684
1%
Headache
1%
Hypertension
1%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
18F-DCFPyL Injection

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: 1/18F-DCFPyL PET/CT + radical prostatectomyExperimental Treatment1 Intervention
18F-DCFPyL PET/CT with radical prostatectomy and lymphadenectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
18F-DCFPyL
2019
Completed Phase 3
~600

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,906 Previous Clinical Trials
41,011,848 Total Patients Enrolled
515 Trials studying Prostate Cancer
332,713 Patients Enrolled for Prostate Cancer
William L Dahut, M.D.Principal InvestigatorNational Cancer Institute (NCI)
11 Previous Clinical Trials
3,536 Total Patients Enrolled
6 Trials studying Prostate Cancer
2,302 Patients Enrolled for Prostate Cancer
Fatima H Karzai, M.D.Principal InvestigatorNational Cancer Institute (NCI)
5 Previous Clinical Trials
12,512 Total Patients Enrolled
1 Trials studying Prostate Cancer
2,000 Patients Enrolled for Prostate Cancer

Media Library

18F-DCFPyL Clinical Trial Eligibility Overview. Trial Name: NCT03976843 — Phase 2
Prostate Cancer Research Study Groups: 1/18F-DCFPyL PET/CT + radical prostatectomy
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL Highlights & Side Effects. Trial Name: NCT03976843 — Phase 2
18F-DCFPyL 2023 Treatment Timeline for Medical Study. Trial Name: NCT03976843 — Phase 2
~23 spots leftby Aug 2025
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