A Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

May 29, 2015 updated by: ImaginAb, Inc.

A Phase 2 Study of Positron Emission Tomography (PET) With [89]Zr-Df-IAb2M in Patients With High-risk Prostate Cancer

This is a prospective, multicenter, open-label, non-randomized study evaluating the ability of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody") chelated with Desferroxamine and radiolabeled with [89]Zr. [89Zr]-Df-IAB2M targets the extracellular domain of Prostate Membrane Specific Antigen (PSMA) expressed on most primary and metastatic prostate cancer lesions.

This is a phase 2, prospective, multi-center, open-label, non-randomized study evaluating the ability of [89]Zr-Df-IAb2M to detect local, regional and metastatic prostate cancer confirmed by pathology in patients with biopsy-proven prostate cancer thought to be candidates for radical prostatectomy and pelvic lymph node dissection who are at high-risk for pelvic lymph node metastasis. These patients may have identified lymphadenopathy on conventional imaging but are considered eligible if still judged to be candidates for radical prostatectomy and lymph node dissection.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Histological diagnosis of prostate adenocarcinoma.
  2. Patients considered candidates for radical prostatectomy and pelvic lymph node dissection. These patients may or may not have identified nodal metastasis on conventional imaging but would still be candidates for radical prostatectomy and pelvic lymph node dissection.
  3. Patients, who are at high-risk for pelvic lymph node metastasis as defined by a lymph node involvement risk of greater than or equal to 20% using the Briganti nomogram.
  4. Age ≥ 18 years.
  5. Ability to understand and willingness to sign IRB approved consent form
  6. For men of child-producing potential, the use of effective contraceptive methods during the study.

Exclusion Criteria:

  1. Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, [89]Zr-Df-IAB2M PET/CT and the surgical resection or biopsy procedures used for the study evaluation.
  2. Unwillingness or inability to comply with procedures required in this protocol.
  3. Other cancers that might potentially interfere with the reading and interpretation of [89]Zr-Df-IAB2M PET/CT scans.
  4. Patients who are currently receiving any other investigational agent.
  5. Patients who have had or are currently receiving androgen deprivation therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [89Zr]Df-IAB2M
A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg.
Radiation: [89Zr]Df-IAB2M
A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
Time Frame: 6 weeks
6 weeks
Specificity of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
Time Frame: 6 weeks
6 weeks
Positive Predicted Value of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
Time Frame: 6 weeks
6 weeks
Negative Predicted Value of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
Time Frame: 6 weeks
6 weeks
Accuracy of [89]Zr-Df-IAb2M PET/CT for the detection of extraprostatic sites of prostate cancer as confirmed by biopsy and/or surgically resected tissue.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
optimal SUVmax and SUVpeak thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results.
Time Frame: 6 weeks
6 weeks
Optimal SUV ratio thresholds on [89]Zr-Df-IAb2M PET/CT for discriminating positive and negative tumor pathology results, where the ratio is calculated using an appropriate reference tissue.
Time Frame: 6 weeks
6 weeks
Sensitivity and specificity of [89]Zr-Df-IAb2M PET/CT compared to the sensitivity and specificity of conventional imaging for the detection of lesions as confirmed by pathology.
Time Frame: 6 weeks
6 weeks
Location and number of positive lesions on [89]Zr-Df-IAb2M PET/CT in subjects with equivocal or negative conventional imaging scans.
Time Frame: 6 weeks
6 weeks
Sensitivity and specificity of [89]Zr-Df-IAb2M PET/CT to identify patients who are positive or negative for metastatic disease as identified by pathology.
Time Frame: 6 weeks
6 weeks
Sensitivity and specificity of IAB2M [89]Zr-Df-IAb2M PET/CT to identify disease as confirmed by pathology individually in each of the resected areas including: left and right external iliac, obturator and internal iliac nodes.
Time Frame: 6 weeks
6 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events or Serious Adverse Events attributable to [89]Zr-Df-IAB2M administration according to MedDRA/CTCAE v. 4.03 as a measure of safety and tolerability.
Time Frame: 12 weeks
12 weeks
Number of Participants with clinically significant changes in physical examination findings, vital signs, and blood chemistry from screening to follow-up analysis as a measure of safety and tolerability.
Time Frame: 12weeks
12weeks
Number of Participants with Anti-drug antibody (ADA) in serum due to [89]Zr-Df-IAB2M injection as a measure of safety and tolerability.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImaginAb, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

March 1, 2016

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

April 14, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

June 2, 2015

Last Update Submitted That Met QC Criteria

May 29, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-2M-04.00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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