Prostate Cancer
Conditions
Keywords
[89Zr]Df-IAB2M, Prostate cancer, PET scan
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.
Interventions
RADIATION[89Zr]Df-IAB2M
Sponsors
ImaginAb, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed