NCT02349022

Brief Summary

The purpose of this study is to compare the diagnostic performance of \[89Zr\]-Df-IAB2M PET/CT with that of \[111In\]-capromab pendetide as an immuno PET tracer in the detection of prostate cancer pre-prostatectomy as confirmed by pathology. Individuals participating in this study will have a \[111In\]-capromab pendetide scan, as well as a PET scan following the injection of \[89Zr\]-Df-IAB2M.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2 prostate-cancer

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_2 prostate-cancer

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

January 1, 2015

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 13, 2020

Status Verified

August 1, 2016

Enrollment Period

1.2 years

First QC Date

January 23, 2015

Last Update Submit

February 10, 2020

Conditions

Prostate Cancer

Keywords

[89Zr]Df-IAB2MProstate cancerPET scan

Outcome Measures

Primary Outcomes (1)

  • Compare sensitivity/specificity/PPV/NPV/Accuracy of [111In] capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT as confirmed by pathology

    6 weeks

Secondary Outcomes (4)

  • Assess the safety of a single dose of [89Zr]-Df-IAB2M

    Day 1 through Day 13

  • Histopathologic correlation of PSMA expression and prostate cancer from surgical or biopsy specimens with uptake of [89Zr]-Df-IAB2M on PET/CT

    Day 1 through Day 13

  • Compare the concordant and discordant rate for positive/negative areas of uptake between [111In]-Capromab pendetide SPECT/CT to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status

    Day 1 through Day 13

  • Compare the sensitivity/specificity/PPV/NPV/Accuracy of conventional imaging (CT/MRI/Bone scan) to [89Zr]-Df-IAB2M PET/CT using pathology for ground truth of disease status

    Day 1 through Day 13

Study Arms (1)

[89Zr]Df-IAB2M

EXPERIMENTAL

A single intravenous infusion of 2.5 mCi of \[89Zr\]Df-IAB2M in a mass dose of 10 mg.

Radiation: [89Zr]Df-IAB2M

Interventions

[89Zr]Df-IAB2MRADIATION
[89Zr]Df-IAB2M

Eligibility Criteria

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

You may qualify if:

  • Patients must meet ALL criteria listed below for entry:
  • Age ≥ 18 years
  • Signed, written IRB-approved informed consent
  • Patients newly diagnosed with biopsy-proven prostate cancer, thought to be a candidate for prostatectomy after standard diagnostic evaluation (e.g. chest x-ray, CT scan or MRI) who are at high-risk for pelvic lymph node metastases.
  • High Risk defined as:
  • Gleason score ≥ 8 or
  • Gleason 4+3 with a PSA \> 10 or
  • PSA \> 20 ng/mL or
  • T3a
  • Patients scheduled for a \[111In\]-capromab pendetide scan or had a recent \[111In\]-capromab pendetide scan within 28 days of screening visit or would be willing to undergo a \[111In\]-capromab pendetide scan
  • Karnofsky Performance status of ≥ 60
  • Life expectancy of at least 6 months
  • Patients with any previous history of another malignancy (other than in-situ cancer, basal or squamous cell skin cancer) must be disease free for a period of three years.
  • Acceptable liver function:
  • Bilirubin ≤ 1.5 times upper limit of normal or \<3 x ULN for patients with Gilbert's disease
  • +9 more criteria

You may not qualify if:

  • Patients will be excluded from entry if ANY of the criteria listed below are met:
  • New York Heart Association Class III or IV, cardiac disease, myocardial infarction within the past 6 months
  • Unstable arrhythmia, or evidence of ischemia on ECG
  • Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
  • Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy for prostate cancer.
  • Unwillingness or inability to comply with procedures required in this protocol
  • Known infection with HIV, hepatitis B, or hepatitis C
  • Serious nonmalignant disease (eg, hydronephrosis, liver failure, or other conditions) that could compromise protocol objectives in the opinion of the investigator and/or the sponsor
  • Previous \[111In\]-capromab pendetide image test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Urology Specialists

Scottsdale, Arizona, 85255, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

89Zr-Df-IAB2M

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

January 23, 2015

First Posted

January 28, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

July 1, 2016

Last Updated

February 13, 2020

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will share

Locations

US(1)