NCT02151760

Brief Summary

This study is being done to determine the safety, biodistribution, and radiation dosimetry of 18F-DCFPyL, and to detect prostate cancer by visual analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2014

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 1, 2014

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

May 28, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

5.9 years

First QC Date

May 28, 2014

Last Update Submit

May 5, 2020

Conditions

Metastatic Prostate Cancer

Keywords

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • PET/CT Detection of Metastatic Disease

    To comare diagnostic accuracy of 18-DCFPyL to CIM(CT and bone scintigraphy) for the detection of metastatic prostate cancer.

    12 months

Study Arms (1)

18F-DCFPyL

EXPERIMENTAL
Drug: 18F-DCFPyL

Interventions

18F-DCFPyLDRUG
Also known as: 10.0 A bolus of less than or equal to 9 mCi (331 MBq) of 18F-DCFPyL will be injected into the IV line by slow push IV push.
18F-DCFPyL

Eligibility Criteria

Age18 Years - 100 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than or equal to 18 years of age
  • Histological confirmation of prostate cancer
  • Radiologic evidence of new or progressive metastatic disease demonstrated on anatomical imaging (CT, MRI, or ultrasound), bone scintigraphy, 18F-Sodium Fluoride PET, or 18F-FDG PET
  • PSA ≥ 1.0 ng/mL
  • Can be on androgen deprivation therapy if dose is stable for ≥ 1 week.
  • Platelet count \> 50,000/mm3
  • Neutrophil count \> 1,000/mm3
  • Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
  • Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

You may not qualify if:

  • Patients will be excluded from enrollment if any of the following apply:
  • Karnovsky performance status of \< 60
  • Inadequate venous access (two antecubital or equivalent venous access sites are required for study drug injection and PK blood sampling, respectively)
  • Patient received a permanent prostate brachytherapy implant within the last 3 months (for Pd-103 implants) or 12 months (for I-125 implants)
  • Administered a radioisotope within 5 physical half-lives prior to study enrollment
  • Serum creatinine \> 3 times the upper limit of normal
  • Total bilirubin \> 3 times the upper limit of normal
  • Liver Transaminases \> 5times the upper limit of normal
  • Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 30 days prior to study radiotracer administration
  • Prior radiation therapy or chemotherapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest).
  • Prior history of any other malignancy within 3 years, other than skin basal cell carcinoma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

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

  • Steve Y Cho, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2014

First Posted

May 30, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations

US(1)