NCT03471650

Brief Summary

This is a phase II, single-center, open-label, trial to evaluate the diagnostic accuracy of PSMA-targeted 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer in a screening population.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2 prostate-cancer

Timeline
22mo left

Started Mar 2018

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2018Mar 2028

First Submitted

Initial submission to the registry

March 2, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

March 29, 2018

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 7, 2028

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

9.9 years

First QC Date

March 2, 2018

Last Update Submit

March 24, 2026

Conditions

Prostate Cancer

Keywords

J17149PSMA18F-DCFPyL PET/CT

Outcome Measures

Primary Outcomes (1)

  • Sensitivity of 18F-DCFPyL PET/CT to detect clinically significant prostate cancer on prostate biopsy relative to serum prostate specific antigen (PSA)

    Measure the diagnostic accuracy of 18F-DCFPyL PET/CT and compare it with serum PSA for detecting clinically significant prostate cancer on prostate biopsy

    4 years

Secondary Outcomes (3)

  • Sensitivity of 18F-DCFPyL PET/CT relative to PSA

    4 years

  • Sensitivity of 18F-DCFPyL PET/CT for detecting clinically significant prostate cancer relative to mpMRI

    4 years

  • Sensitivity and diagnostic accuracy of 18F-DCFPyL PET/CT relative to the phi blood test for detecting clinically significant prostate cancer by the various tested definitions

    4 years

Study Arms (1)

18F-DCFPyL Injection

EXPERIMENTAL

A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

Drug: 18F-DCFPyL Injection

Interventions

18F-DCFPyL InjectionDRUG

A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.

Also known as: PyL
18F-DCFPyL Injection

Eligibility Criteria

Age18 Years+
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsStudy is For Prostate Cancer in Men
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years of age
  • PSA of 2-10 ng/mL
  • Clinical stage T1c-T2a on digital rectal exam
  • Elect to undergo TRUS-guided prostate biopsy as part of routine clinical care
  • Willingness to sign informed consent and comply with all protocol requirements

You may not qualify if:

  • History of prior prostate biopsy
  • Administered a radioisotope ≤5 physical half-lives prior to the date of study PET/CT
  • Administered IV X-ray contrast medium ≤24 hours prior to the date of study PET/CT
  • Administered oral contrast medium ≤120 hours prior to the date of study PET/CT
  • Any medical condition or other circumstances that in the opinion of the investigators compromise obtaining reliable data or achieving the study objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SKCCC

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

2-(3-(1-carboxy-5-((6-fluoropyridine-3-carbonyl)amino)pentyl)ureido)pentanedioic acid

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Mohamad Allaf, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2018

First Posted

March 20, 2018

Study Start

March 29, 2018

Primary Completion (Estimated)

March 7, 2028

Study Completion (Estimated)

March 7, 2028

Last Updated

March 30, 2026

Record last verified: 2026-03

Locations

US(1)