NCT03497377

Brief Summary

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFPyL (DCFPyL) PET/CT (or PET/MRI imaging if available) for detection of metastatic prostate cancer. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness and metastatic potential. Preliminary first-in-human studies demonstrate high specific uptake of a first generation less avid compound, DCFBC, in metastatic prostate cancer and demonstrated feasibility for prostate cancer metastatic detection. Investigators propose to assess the ability of DCFPyL PET to detect metastatic prostate cancer by visual qualitative and quantitative SUV analysis. Correlation will be made to sites of suspected metastatic disease detected by ultra sensitive but less specific \[18F\]Sodium Fluoride (NaF)-PET/CT imaging for prostate cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2016

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

First Submitted

Initial submission to the registry

May 12, 2016

Completed
4 days until next milestone

Study Start

First participant enrolled

May 16, 2016

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2 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

3.9 years

First QC Date

May 12, 2016

Last Update Submit

May 5, 2020

Conditions

Metastatic Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Comparison of DCFPyL- PET/CT (or PET/MRI imaging) to NaF-PET/CT

    Compare the diagnostic accuracy during visit 2 18F-DCFPyL imaging and visit 3 NaF imaging

    4 years

Secondary Outcomes (1)

  • Estimation of new or progressive metastatic lesions found on NaF and 18F-DCFPyL

    4 years

Study Arms (1)

18F-DCFPyL Injection & 18F-NaF

EXPERIMENTAL

A bolus of \~9 mCi (333 MBq) of 18F-DCFPyL injected by slow IV push. A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose

Drug: 18F-DCFPyL InjectionDrug: 18F-NaF

Interventions

18F-DCFPyL InjectionDRUG
18F-DCFPyL Injection & 18F-NaF
18F-NaFDRUG
18F-DCFPyL Injection & 18F-NaF

Eligibility Criteria

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

You may qualify if:

  • 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, and/or \[18F\]FDG PET
  • Rising PSA on two observations taken at least 1 week apart
  • Adequate peripheral venous access or available central venous catheter access for radiopharmaceutical administration
  • Patient can remain on androgen deprivation therapy if on the same regimen prior to documentation of progressive metastatic disease
  • Patient cannot start a new therapy for prostate cancer prior to study radiopharmaceutical imaging
  • 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:

  • Patient has been treated with an investigational drug, investigational biologic, or investigational therapeutic device within 14 days prior to study radiotracer administration
  • Prior radiation therapy, chemotherapy, or androgen-deprivation therapy within 2 weeks prior to study radiotracer administration (Washout is one half-life of the drug or 2 weeks, whichever is longest)
  • Initiation of new therapy for progressive metastatic disease since radiographic documentation of progression.
  • 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
  • Unable to lie flat during or tolerate PET/CT (or PET/MRI imaging if available)
  • Prior history of any other malignancy within last 2 years, other than skin basal cell carcinoma or superficial bladder cancer.

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

  • Martin Pomper, MD,PhD

    Department of Nuclear Medicine

    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 12, 2016

First Posted

April 13, 2018

Study Start

May 16, 2016

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations

US(1)