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

Prostate Cancer Clinical Trial

Official title:

A Phase 2 Study - Comparison Of Positron Emission Tomography (PET/CT) With [89Zr]-Df-IAb2M and [111In]-Capromab Pendetide in the Detection of Prostate Cancer Pre-prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02349022
• Other study ID #: 2014-2M-03.00
• Status: Completed
• Phase: Phase 2
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: ImaginAb, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• [89Zr]Df-IAB2M

Locations

Country	Name	City	State
United States	Arizona Urology Specialists	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ImaginAb, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assess the safety of a single dose of [89Zr]-Df-IAB2M		Day 1 through Day 13
Secondary	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
Secondary	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
Secondary	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