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18F-DCFPyL Imaging for Prostate Cancer

Phase < 1
Recruiting
Led By Steve Y Cho, MD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Prostate biopsy histology grade ≥ Gleason 1, 6, 3+4, or 4+3; positive biopsy >2 cores
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one study visit (up to 3.5 hours)
Awards & highlights

Study Summary

This trial is testing whether a new imaging technique can detect prostate cancer and distinguish between different types of the disease.

Who is the study for?
This trial is for men with prostate cancer, who may have metastatic disease and are fit for a prostatectomy. It includes those newly diagnosed or undergoing biopsy evaluation, with no recent chemotherapy or investigational therapy. Participants should not have had prior pelvic radiation and must be able to undergo PET/CT scans.Check my eligibility
What is being tested?
The study tests the effectiveness of a new imaging biomarker called 18F-DCFPyL PET in detecting, tracking progression, and recurrence of prostate cancer. The goal is to distinguish between aggressive and indolent cancer types to tailor treatment plans.See study design
What are the potential side effects?
As this trial focuses on an imaging technique rather than a drug intervention, side effects are minimal but may include discomfort from lying flat during the scan or reactions related to contrast agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer biopsy shows a Gleason score of 6 or higher with more than 2 positive cores.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one study visit (up to 3.5 hours)
This trial's timeline: 3 weeks for screening, Varies for treatment, and one study visit (up to 3.5 hours) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Positron-Emission Tomography
Malignant Neoplasms
Evaluate 18F-DCFPyL PSMA-based PET for localization for Sub-Study 2: Biochemical Recurrence
+1 more
Secondary outcome measures
Magnetic Resonance Imaging
Sub-Study 1: Low-dose CT versus MRI derived PET SUV
Sub-Study 1: Specificity of 18F-DCFPyL
+12 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: 18F-DCFPyL PETExperimental Treatment1 Intervention
Four separate substudies evaluating 18F-DCFPyL PET imaging of prostate cancer in four prostate cancer clinical scenarios under the following subheadings: (1) primary prostate cancer, (2) biochemical recurrence post-prostatectomy prior to radiation therapy, (3) androgen-resistant metastatic disease and (4) detection of clinically significant prostate cancer in low to intermediate risk primary prostate cancer

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,450 Total Patients Enrolled
33 Trials studying Prostate Cancer
8,862 Patients Enrolled for Prostate Cancer
Steve Y Cho, MDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
15 Total Patients Enrolled

Media Library

18F-DCFPyL PET Clinical Trial Eligibility Overview. Trial Name: NCT03232164 — Phase < 1
Prostate Cancer Research Study Groups: 18F-DCFPyL PET
Prostate Cancer Clinical Trial 2023: 18F-DCFPyL PET Highlights & Side Effects. Trial Name: NCT03232164 — Phase < 1
18F-DCFPyL PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT03232164 — Phase < 1

Frequently Asked Questions

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

Are there other published investigations that have employed the use of 18F-DCFPyL PET?

"As of now, there are currently 18 medical experiments utilizing the radioactive tracer 18F-DCFPyL PET. None of these trials have moved into Phase 3 yet and 27 locations across the United States are taking part in this research with a heavy focus on Baltimore, Maryland."

Answered by AI

What indications has 18F-DCFPyL PET been used to diagnose?

"18F-DCFPyL PET is a common solution for elevated serum prostate specific antigen levels. Additionally, this imaging procedure can be employed to detect metastasis, confirm positron emission tomography results, and treat recurrent bouts of prostate cancer."

Answered by AI

Is this research endeavor currently looking for participants?

"According to the latest update on clinicaltrials.gov, this medical trial is currently seeking enrolment and was first announced back in February 2017. The records were most recently revised on July 12th 2022."

Answered by AI

What core outcomes is this assessment attempting to investigate?

"This clinical trial's primary objective, which will be assessed in a single visit of up to 3.5 hours, is to evaluate the rate of positive cancer detection using PET/MRI directed MRI/transrectal ultrasound (TRUS) fusion biopsy with and without additional PSMA PET information. Secondary objectives include correlating 18F-DCFPyL PET standardised uptake values (SUV) and MRI parameters with prostatectomy pathology IHC; comparing whole body 18F-DCFPyL PET scans, pelvic MR-MRI, and whole body DWI for initial staging compared to conventional imaging modalities such as CT or bone"

Answered by AI

What is the projected enrollment for this clinical investigation?

"Confirmed, according to the clinicaltrials.gov database this study is actively recruiting participants. It was initially posted on February 2nd 2017 and last edited July 12th 2022 - with 104 volunteers required from one location."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer
2017. "PSMA-based 18F-DCFPyL PET/CT and PET/MRI Pilot Studies in Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03232164.
~8 spots leftby Dec 2024
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