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Clin Cancer Res. 2015 Dec 1;21(23):5277-85. doi: 10.1158/1078-0432.CCR-15-0552. Epub 2015 Jul 14.

A Phase I/II Study for Analytic Validation of 89Zr-J591 ImmunoPET as a Molecular Imaging Agent for Metastatic Prostate Cancer.

Author information

1
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York. Department of Radiology, Weill Cornell Medical College, New York, New York. pandit-n@mskcc.org.
2
Department of Medical Physics, Memorial Sloan Kettering Cancer Center, New York, New York.
3
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
4
Molecular Pharmacology and Chemistry Program, Memorial Sloan Kettering Cancer Center, New York, New York. Radiochemistry and Molecular Imaging Probe Core Facility, Memorial Sloan Kettering Cancer Center, New York, New York.
5
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York. Molecular Pharmacology and Chemistry Program, Memorial Sloan Kettering Cancer Center, New York, New York.
6
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York. Department of Radiology, Weill Cornell Medical College, New York, New York.
7
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
8
Department of Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
9
Department of Pathology, Dana-Farber Cancer Institute; Brigham & Women's Hospital; and Broad Institute, Boston, Massachusetts.
10
Department of Medicine, Weill Cornell Medical College, New York, New York.
11
Department of Radiology, Weill Cornell Medical College, New York, New York. Molecular Pharmacology and Chemistry Program, Memorial Sloan Kettering Cancer Center, New York, New York. Radiochemistry and Molecular Imaging Probe Core Facility, Memorial Sloan Kettering Cancer Center, New York, New York.
12
Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
13
Department of Medicine, Weill Cornell Medical College, New York, New York. Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.
14
Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. Department of Medicine, Weill Cornell Medical College, New York, New York.
15
Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York. Department of Radiology, Weill Cornell Medical College, New York, New York. Molecular Pharmacology and Chemistry Program, Memorial Sloan Kettering Cancer Center, New York, New York.

Abstract

PURPOSE:

Standard imaging for assessing osseous metastases in advanced prostate cancer remains focused on altered bone metabolism and is inadequate for diagnostic, prognostic, or predictive purposes. We performed a first-in-human phase I/II study of (89)Zr-DFO-huJ591 ((89)Zr-J591) PET/CT immunoscintigraphy to assess performance characteristics for detecting metastases compared with conventional imaging modalities (CIM) and pathology.

EXPERIMENTAL DESIGN:

Fifty patients with progressive metastatic castration-resistant prostate cancers were injected with 5 mCi of (89)Zr-J591. Whole-body PET/CT scans were obtained, and images were analyzed for tumor visualization. Comparison was made to contemporaneously obtained bone scintigraphy and cross-sectional imaging on a lesion-by-lesion basis and with biopsies of metastatic sites.

RESULTS:

Median standardized uptake value for (89)Zr-J591-positive bone lesions (n = 491) was 8.9 and for soft-tissue lesions (n = 90), it was 4.8 (P < 0.00003). (89)Zr-J591 detected 491 osseous sites compared with 339 by MDP and 90 soft-tissue lesions compared with 124 by computed tomography (CT). Compared with all CIMs combined, (89)Zr-J591 detected an additional 99 osseous sites. Forty-six lesions (21 bone and 25 soft tissue) were biopsied in 34 patients; 18 of 19 (89)Zr-J591-positive osseous sites and 14 of 16 (89)Zr-J591-positive soft tissue sites were positive for prostate cancer. The overall accuracy of (89)Zr-J591 was 95.2% (20 of 21) for osseous lesions and 60% (15 of 25) for soft-tissue lesions.

CONCLUSIONS:

(89)Zr-J591 imaging demonstrated superior targeting of bone lesions relative to CIMs. Targeting soft-tissue lesions was less optimal, although (89)Zr-J591 had similar accuracy as individual CIMs. This study will provide benchmark data for comparing performance of proposed prostate-specific membrane antigen (PSMA) targeting agents for prostate cancer.

PMID:
26175541
PMCID:
PMC4668231
DOI:
10.1158/1078-0432.CCR-15-0552
[Indexed for MEDLINE]
Free PMC Article

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