comparison of pet with [89zr]-df-iab2m and [111in]-capromab pendetide in the detection of prostate cancer pre-prostatectomy

Conditions: Prostate Cancer

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.

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.

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

Keywords: [89zr]df-iab2m prostate cancer pet scan