NCT03852654

Brief Summary

Primary Objective: The primary objective of this study is to assess the efficacy of 18F-DCFPyL PET-CT for initial staging of prostate cancer in Veterans compared to conventional imaging (99mTc-MDP bone scan and Diagnostic CT or MRI). The primary clinical endpoint of our study is the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging. Secondary Objectives: Frequency of the change in primary treatment plan after initial staging.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

July 22, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 25, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

February 21, 2019

Last Update Submit

February 21, 2019

Conditions

Prostate Cancer Adenocarcinoma

Keywords

Prostate Cancer, PET CT scan, 18F-DCFPyL

Outcome Measures

Primary Outcomes (1)

  • the percent of Veterans with prostate cancer in which the 18F-DCFPyL PET-CT identifies M1 disease at initial staging

    120 days

Study Arms (1)

treatment

EXPERIMENTAL
Drug: 18F-DCFPyL

Interventions

18F-DCFPyLDRUG

Subjects with biopsy proven prostate cancer, no prior local therapy, and: PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan.

treatment

Eligibility Criteria

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

You may qualify if:

  • Age ≥ 18 years and male.
  • Ability to understand the study and the willingness to sign a written informed consent document.
  • Histologically confirmed adenocarcinoma of the prostate.
  • PSA greater than 10, or Gleason ≥4+3, or clinical stage greater than or equal toT2c.
  • Plan to undergo (or have already undergone) routine care initial systemic staging with conventional imaging for prostate cancer.
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0 to 2.
  • No prior local therapy for prostate cancer (i.e., prostatectomy, radiotherapy, etc.).
  • Willing to comply with the procedural requirements of this protocol.

You may not qualify if:

  • Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection.
  • The subject has a condition or situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study.
  • Primary small cell carcinoma of the prostate.
  • Participation in this study significantly delay the scheduled standard of care therapy.
  • Weighs greater than 350 lbs., or unable to fit within the imaging gantry.
  • The subject undergone prior local therapy for prostate cancer (i.e. prostatectomy, radiotherapy, etc.).
  • Currently receiving androgen deprivation therapy (ADT) or anti-androgen? Previous use of ADT is allowed IF the subject has been off ADT or anti-androgen for 3 months or more.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles

Los Angeles, California, 90073, United States

RECRUITING

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

Central Study Contacts

Jafari Lida, M.D.

CONTACT

310 268 3583lida.jafari@va.gov

Nicholas G Nickols, M.D., Ph.D.

CONTACT

310 268 3390nicholas.nickols@va.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nuclear Medicine Physician

Study Record Dates

First Submitted

February 21, 2019

First Posted

February 25, 2019

Study Start

July 22, 2018

Primary Completion

December 30, 2019

Study Completion

June 30, 2020

Last Updated

February 25, 2019

Record last verified: 2019-02

Locations

US(1)