Comparison of PET With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-Prostatectomy

NCT ID: NCT02349022

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-07-31

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.

Detailed Description

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

[111In]-capromab pendetide (Prostascint®) is an FDA approved imaging agent targeting the intracellular domain of PSMA. It is anticipated that [89Zr]-Df-IAB2M will outperform Prostascint® because of this targeting difference.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

[89Zr]Df-IAB2M

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

Group Type: EXPERIMENTAL

[89Zr]Df-IAB2M

Intervention Type: RADIATION

Interventions

[89Zr]Df-IAB2M

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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
• AST (SGOT), ALT (SGPT) and Alkaline phosphatase ≤ 2.5 times upper limit of normal (if liver metastases are present, then ≤ 5 x ULN is allowed)
• Acceptable renal function:

• Serum creatinine within normal limits, OR
• calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• Acceptable hematologic status:

• Granulocyte ≥ 1500 cells/mm3
• Platelet count ≥ 150,000 (plt/mm3)
• Hemoglobin ≥ 9 g/dL
• For men of child-producing potential, the use of effective contraceptive methods during the study

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

ImaginAb, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arizona Urology Specialists

Scottsdale, Arizona, United States

Countries

United States

Other Identifiers

2014-2M-03.00

Identifier Type: -

Identifier Source: org_study_id