18F- DCFPyL PET/CT for Prostate Cancer

Columbia University Medical Center, New York, NY
18F- DCFPyL PET/CTPhase 2 & 3Waitlist AvailableLed by Emerson Lim, MDResearch Sponsored by Columbia University

Study Summary

This trial is testing a new imaging agent, [18F] PyL, to see if it can better detect metastatic prostate lesions than standard imaging. So far it seems to be working well, but more research is needed to see if it can help predict which patients will respond to certain therapies.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 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
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-patient basis
Secondary outcome measures
To determine the positive predictive value of 18F-DCFPyL PET/CT on a per-region basis, with regions being the prostate or prostate bed, pelvis, extra pelvis, and bones
To determine the sensitivity and specificity of 18F-DCFPyL PET/CT on a per patient and region basis
Other outcome measures
To characterize ctDNA and exosomes in patients with prostate cancer
To determine correlation with ctDNA and/or exosome levels with disease burden

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
Upon enrollment, subjects will undergo standard of care imaging (defined as a CT or MRI of the chest, abdomen, and pelvis, and 99mTc bone scans) if not obtained within 45 days of enrollment. Subjects will have standard of care laboratory evaluations including complete blood count (CBC), serum chemistries, hepatic panel, lactate dehydrogenase (LDH), and PSA. Liquid biopsies for circulating tumor DNA (ctDNA) and exosome analysis will occur at the same time. Subjects will then undergo 18F- DCFPyL PET/CT.

Find a site

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,372 Previous Clinical Trials
1,782,307 Total Patients Enrolled
14 Trials studying Prostate Cancer
36,511 Patients Enrolled for Prostate Cancer
Emerson Lim, MDPrincipal Investigator
Assistant Professor of Medicine
2 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Prostate Cancer
9 Patients Enrolled for Prostate Cancer
Matthew C. Dallos, MDPrincipal Investigator
Assistant Professor of Medicine
1 Previous Clinical Trials
11 Total Patients Enrolled

Media Library

18F- DCFPyL PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT03824275 — Phase 2 & 3
Prostate Cancer Research Study Groups: 18F- DCFPyL PET/CT
Prostate Cancer Clinical Trial 2023: 18F- DCFPyL PET/CT Highlights & Side Effects. Trial Name: NCT03824275 — Phase 2 & 3
18F- DCFPyL PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03824275 — Phase 2 & 3

Frequently Asked Questions

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

Are there any current openings for willing participants in this clinical trial?

"As of this moment, the clinical trial mentioned is not currently recruiting patients. This is according to the latest information on clinicaltrials.gov, which was last updated on May 6th, 2022. Although this specific study has closed recruitment, there are 1289 other trials that are still looking for participants."

Answered by AI
~23 spots leftby Sep 2024