TheranosticTrials.org

Clinical Trial · NCT02349022

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

Overview

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.

Sponsor

Imagine AB, Inc.

Phase

Phase 2

ClinicalTrials.gov

NCT02349022

Drug / Compound

Df-IAB2M

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Proteins and Antibody Fragments
Chelator: Desferroxamine

capromab pendetide

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Antibodies
Chelator: DTPA
Linker: GYK-DTPA-HCl

Eligibility

Inclusion

  • 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
  • T3a
  • 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)
  • Gleason 4+3 with a PSA \> 10 or
  • calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
  • 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.
  • PSA \> 20 ng/mL or
  • Karnofsky Performance status of ≥ 60
  • Granulocyte ≥ 1500 cells/mm3
  • Acceptable renal function:
  • 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
  • Acceptable hematologic status:
  • Life expectancy of at least 6 months
  • Serum creatinine within normal limits, OR
  • Acceptable liver function:
  • Gleason score ≥ 8 or
  • Bilirubin ≤ 1.5 times upper limit of normal or \<3 x ULN for patients with Gilbert's disease
  • Patients must meet ALL criteria listed below for entry:
  • High Risk defined as:

Exclusion

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