Methods of detecting prostate cancer
Inventors
Kassis, Amin I. • Stylli, Harry • Kelly, Colleen • Erickson, Geoffrey • Wojno, Kirk J.
Assignees
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Publication Number
US-11585814-B2
Publication Date
2023-02-21
Expiration Date
Abstract
The invention described herein provides biological markers for the diagnosis, prognosis, and monitoring of prostate cancer.
Core Innovation
The invention relates to measuring prostate cancer marker levels in phagocytic immune cells compared to non-phagocytic cells from the same subject. The approach uses differential levels of defined marker sets measured in macrophage cells or neutrophil cells and in T-cells, using gene expression, protein expression, or protein activity assays, including amplification assay, sequencing assay, or immunoassay.
The method performs measurements at a first time point and then again at a second time point to assess change associated with prostate cancer. Measurements are taken before a treatment for prostate cancer and/or before administering a compound, and then are repeated after the treatment and/or after administering the compound.
Specific exemplified marker sets include PC-MACRO markers comprising P2RY10, TNFAIP3, CXCR1, DNAJB1, and CHI3L1, and PC-NEUTRO markers comprising EIF3S5, EEF1A1, RPL14, RPL23A, RPL3, RPS28, and PTMA. The framework includes paired phagocyte-versus-T-cell comparisons and uses microarray-derived signatures with validation and cross-validation statistical support.
Claims Coverage
The provided text includes three independent method claims. Across the independent claims, the core inventive features require measuring differential marker levels in subject phagocytic cells and in subject T-cells using defined marker sets and assay types, with paired pre-treatment versus post-treatment measurements for prostate cancer and compound administration.
Macrophage and T-cell marker-level measurement before and after treatment
Measuring levels of two to five markers selected from P2RY10, TNFAIP3, CXCR1, DNAJB1, and CHI3L1 in a population of the subject's macrophage cells using an amplification assay, a sequencing assay, or an immunoassay before a treatment for prostate cancer, before administering a compound, or at a first time point, and measuring the levels in a population of the subject's T-cells before the treatment, before administering the compound, or at the first time point. Re-measuring the levels in macrophage cells and T-cells after the treatment, after administering the compound, or at a second time point.
Neutrophil and T-cell marker-level measurement before and after treatment
Measuring levels of two to seven markers selected from EIF3S5, EEF1A1, RPL14, RPL23A, RPL3, RPS28, and PTMA in a population of the subject's neutrophil cells using an amplification assay, a sequencing assay, or an immunoassay before a treatment for prostate cancer, before administering a compound, or at a first time point, and measuring the levels in a population of the subject's T-cells before the treatment, before administering the compound, or at the first time point. Re-measuring the levels in neutrophil cells and T-cells after the treatment, after administering the compound, or at a second time point.
Combined macrophage and neutrophil marker panels with paired T-cell measurements
Measuring two to five first markers selected from P2RY10, TNFAIP3, CXCR1, DNAJB1, and CHI3L1 in macrophage cells and measuring two to seven second markers selected from EIF3S5, EEF1A1, RPL14, RPL23A, RPL3, RPS28, and PTMA in neutrophil cells using an amplification assay, a sequencing assay, or an immunoassay before a treatment for prostate cancer, before administering a compound, or at a first time point, and measuring both marker sets in T-cells before the treatment, before administering the compound, or at the first time point. Re-measuring both marker sets in macrophage cells and neutrophil cells after the treatment, after administering the compound, or at a second time point, and re-measuring both marker sets in T-cells after the treatment, after administering the compound, or at a second time point.
Across the independent claims, coverage centers on paired measurement of defined marker sets in macrophages and/or neutrophils and in subject T-cells using amplification assays, sequencing assays, or immunoassays. Each independent claim requires comparing measurements before and after prostate cancer treatment and/or before and after administering a compound via first and second time points.
Stated Advantages
Paired phagocyte-versus-T-cell comparisons improve discrimination versus unpaired comparisons.
Documented Applications
Diagnostic, prognostic, and monitoring approaches for prostate cancer using differential marker levels with pre- and post-treatment or timepoint comparisons to assess therapy efficacy and progression or regression.
Compound identification using differential marker-level responses measured before and after administering a compound.
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