18F-DCFPyL for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate Cancer18F-DCFPyL - Drug
Eligibility
18 - 89
Male
What conditions do you have?
Select

Study Summary

This trial will help researchers learn if PET-MR using PyL is accurate in diagnosing prostate cancer and finding out how far the cancer has spread.

Eligible Conditions
  • Prostate Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 years

5 years
PET/MR versus mp-MRI for the Staging of Newly Diagnosed Prostate Cancer

Trial Safety

Side Effects for

18F-DCFPyL Injection
1%Hypertension
1%Headache
1%Fatigue
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT03739684) in the 18F-DCFPyL Injection ARM group. Side effects include: Hypertension with 1%, Headache with 1%, Fatigue with 1%.

Trial Design

1 Treatment Group

18F-DCFPyL
1 of 1

Experimental Treatment

48 Total Participants · 1 Treatment Group

Primary Treatment: 18F-DCFPyL · No Placebo Group · Phase < 1

18F-DCFPyL
Drug
Experimental Group · 1 Intervention: 18F-DCFPyL · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Piflufolastat F 18
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,458 Previous Clinical Trials
790,047 Total Patients Enrolled
18 Trials studying Prostate Cancer
2,928 Patients Enrolled for Prostate Cancer
Progenics Pharmaceuticals, Inc.Industry Sponsor
30 Previous Clinical Trials
4,790 Total Patients Enrolled
16 Trials studying Prostate Cancer
2,264 Patients Enrolled for Prostate Cancer
Edward Schaeffer, MD/PhDPrincipal Investigator - Chair, Department of Urology
Northwestern Lake Forest Hospital, Northwestern Memorial Hospital
University Of Chicago (Medical School)
Johns Hopkins University School Medicine (Residency)

Eligibility Criteria

Age 18 - 89 · Male Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to understand and sign a written informed consent prior to registration on study.
You have a biopsy-proven diagnosis of high risk, very high risk, or locally advanced prostate cancer.
You are not a candidate for surgery because you are not in good enough health.
You must be age ≥ 18 years.