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Algorithms and methods for assessing late clinical endpoints in prostate cancer

A Prostate Cancer, Clinical Outcomes Technology, applied in the field of clinical management options for at-risk prostate cancer patients, to address issues such as inaccurate estimates of individual patient risk and lack of reproducibility

Pending Publication Date: 2019-09-27
基美健有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Consequently, existing pathological staging methods have been criticized for lacking reproducibility and thus may provide imprecise estimates of individual patient risk

Method used

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  • Algorithms and methods for assessing late clinical endpoints in prostate cancer
  • Algorithms and methods for assessing late clinical endpoints in prostate cancer
  • Algorithms and methods for assessing late clinical endpoints in prostate cancer

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0167] Example 1: Risk of Clinical Relapse (CR) and Prostate Cancer Death (PCD) Associated with GPS Results <20

[0168] Two large longitudinal prostate cancer cohorts were analyzed to assess the risk of CR and PCD with GPS 20 units (range 0 to 100). Patient data from E. Klein et al., Eur Urol 66:550-560 (2014) and J. Cullen et al., Eur Urol 68:123-131 (2015) were analyzed to determine a cut-off point with the pre-established GPS of 20 Associated CR and PCD risks. For more details on the baseline characteristics of the patients in this study, see Table 1 of E. Klein et al., Eur Urol 66:550-560 (2014) and Table 1 of J. Cullen et al., Eur Urol 68:123-131 (2015). Table 1.

[0169] Patients were stratified according to the value of GPS (≤20 or >20). Cox regression analysis accounted for group sampling weights. This is due to the fact that the GPS was developed using the Klein standardized hazard ratio (std HR, HR for a 1 standard deviation (SD) change in the covariate) for GP...

Embodiment 2

[0173] Example 2: GPS Results ≤40 and >40 and Risk of Distant Metastasis and Prostate Cancer Death in Prostate Cancer Patients

[0174] The initial selection of 259 patients was selected from 6184 men with prostate cancer at very low to high NCCN risk in a large community-based US general health care system from 1995-2010. Specifically, among 6184 eligible patients, 404 patients were selected according to a prespecified group sampling protocol, of whom 334 had available biopsies. Fourteen (4%) were excluded due to clinical ineligibility and 41 (12%) were excluded due to insufficient or incorrect tumor type. Of the remaining 279, 259 (93%) patients had valid GPS results and represented the final evaluable population. The 259 patients included 5 in the very low-risk group, 35 in the low-risk group, 160 in the intermediate-risk group, and 57 in the high-risk group. The table below provides the characteristics of the 259 evaluable patients.

[0175] Table 2

[0176]

[0177...

Embodiment 3

[0205] Example 3: GPS Results ≤40 and >40 and Risk of Clinical Relapse (CR) and Biochemical Relapse (BCR) in Prostate Cancer Patients

[0206] In two other studies, patient data from E. Klein et al., Eur Urol 66:550-560 (2014) and J. Cullen et al., Eur Urol 68:123-131 (2015) were analyzed to consider high How GPS results at or below 40 correlate with BCR and CR in intermediate-risk patients. For more details on the baseline characteristics of patients in these studies, see Table 1 of E. Klein et al., Eur Urol 66:550-560 (2014) and Table 1 of J. Cullen et al., Eur Urol 68:123-131 (2015). Table 1.

[0207] A study of prostate cancer patients from the Cleveland Clinic (Cleveland Clinic, CC) database (described in E. Klein et al., Eur Urol 66:550-560 (2014)) showed that 4.7% of patients in the AUA intermediate risk group with GPS≤40 The RM-adjusted risk of clinical recurrence (CR) within 10 years, while AUA intermediate-risk patients with GPS>40 had a RM-adjusted 10-year CR risk...

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Abstract

The present disclosure relates to uses of a multiple gene-expression based Genomic Prostate ScoreTM (GPSTM ) algorithm for assessment of various clinical endpoints in prostate cancer patients, such as risks of clinical recurrence (CR), biochemical recurrence (BCR), distant metastasis (Mets), and prostate cancer death (PCD). In some embodiments, GPS result is determined for low and intermediate risk prostate cancer patients in order to assist in determining treatment strategies for those patients.

Description

[0001] Cross References to Related Applications [0002] This application claims U.S. Provisional Patent Application No. 62 / 458,474, filed February 13, 2017, U.S. Provisional Patent Application No. 62 / 473,204, filed March 17, 2017, and U.S. Provisional Patent Application No. 6, filed October 30, 2017 62 / 578,622 priority interest. technical field [0003] This disclosure relates to prostate genome scoring based on polygene expression TM (GPS TM ) test algorithm was used to assess the risk of various clinical endpoints such as clinical recurrence (CR, also referred to herein as metastasis), biochemical recurrence (BCR), distant metastasis (Met) and prostate cancer death (PCD) in prostate cancer patients ), and in some embodiments relates to the use for determining clinical management options for low- and intermediate-risk prostate cancer patients. Background technique [0004] The introduction of prostate-specific antigen (PSA) screening in 1987 led to the diagnosis and ag...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C12Q1/6809C12Q1/6886
CPCC12Q1/6809C12Q1/6886C12Q2600/118C12Q2600/158C12Q2537/165G16B25/10G16H50/30
Inventor 吕睿皛M·克拉格N·张T·曼达拉P·菲博H·J·劳伦斯
Owner 基美健有限公司
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