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18F-DCFPyL PET/CT for Prostate Cancer

Phase 2 & 3

Waitlist Available

Led By Emerson Lim, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

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

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.

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Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,704 Total Patients Enrolled

14 Trials studying Prostate Cancer

22,592 Patients Enrolled for Prostate Cancer

Emerson Lim, MDPrincipal InvestigatorAssistant 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 InvestigatorAssistant 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

Recent research and studies

clinicaltrials.govStudy

18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer

Matthew Dallos 2019. "18F-DCFPyL Positron Emission Tomography (PET)/Computed Tomography (CT) in Men With Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03824275.