Phase I/IIA Study of PET Imaging With 89Zr-Df-IAB2M in Metastatic Prostate Cancer

Phase 1

Completed

Brief Summary: This is a Phase I/IIa study evaluating the safety and feasibility of \[89Zr\]Df-IAB2M as an immunoPET tracer for metastatic prostate cancer. Individuals participating in this study will have a FDG PET scan, as well as four (4) PET scans (over a 3 day period) following the injection of \[89Zr\]Df-IAB2M PET tracer. Three different dosing levels will be explored. The purpose of the study is to demonstrate the safety of \[89Zr\]Df-IAB2M, ability to detect prostate cancer, and optimal time point and dose level for imaging.

Detailed Description: IAB2M is an approximately 80 kDA molecular weight antibody fragment (a "Minibody"). Limited (Phase 0/Proof-of-concept) patient experience with this biologic targeting agent has been previously obtained with SPECT imaging Ex-US, demonstrating targeting of soft tissue and bone lesions in advanced metastatic prostate cancer.

Recruitment & Eligibility

Inclusion Criteria

Adult male >/= 18 years of age
Patients with histologically confirmed prostate cancer
Progressive disease manifest (within 6 weeks of screening) by either
- imaging modalities (bone scan, MRI or CT) OR
- biochemical progression (PSA)
Performance status of 60 or higher on Karnofsky scale
Subject's schedule permits compliance with all study procedures
Ability to understand and willingness to sign a written informed consent form

Exclusion Criteria

Previous anaphylactic reaction to huJ591 antibody or FDG imaging
On any new anticancer therapy (GnRH analog allowed) while on the study
Hepatic lab values: Bilirubin>1.5 ULN; AST/ALT >2.5 ULN; Albumin < 2 g/dL; GGT > 2.5 ULN if Alkaline Phostphatase >2.5 ULN
Renal lab values: Creatinine > 1.5 ULN
Other severe acute or chronic medical condition that may increase the risk associated with study participation or investigational product administration

Arm && Interventions

Group	Intervention	Description
[89Zr]Df-IAB2M	[89Zr]Df-IAB2M	A single intravenous infusion of 5 mCi of \[89Zr\]Df-IAB2M in mass doses of either 10 mg, 20 mg or 50 mg (optional).

Primary Outcome Measures

Name	Time	Method
Determine the safety of [89Zr]Df-IAB2M PET in patients with metastatic prostate cancer.	Day 1 (Infusion Day) through Day 7	To assess the safety of a single dose of of \[89Zr\]Df-IAB2M

Secondary Outcome Measures

Name	Time	Method
Sensitivity of [89Zr]Df-IAB2M to detect metastatic prostate cancer	Up to 4 weeks	To compare the results of the biopsy and FDG PET scan to the \[89Zr\]Df-IAB2M images
Optimal parameters for imaging with [89Zr]Df-IAB2M	Day 1 (Infusion Day) to Day 3	To evaluate the mass dose and hours post infusion that provides optimal detection of metastatic prostate cancer
[89Zr]Dr-IAB2M PET/CT quantitative assessment of metastatic prostate cancer	Day 1 (Infusion Day) to Day 3	To determine the ability of 89Zr-Df-IAb2M PET to detect known sites of disease in patients with metastatic prostate cancer