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

Phase 2

Completed

Conditions: Prostate Cancer

Interventions: Radiation: [89Zr]Df-IAB2M

Registration Number: NCT02349022

Lead Sponsor: ImaginAb, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 19

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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