MiRNA-based predictive models for diagnosis and prognosis of prostate cancer

Patent metadata

Field	Value
Publication number	US-10480033-B2
Application number	US-201615543721-A
Country	US
Kind code	B2
Filing date	Jan 14, 2016
Priority date	Jan 14, 2015
Publication date	Nov 19, 2019
Grant date	Nov 19, 2019

Abstract

The lack of clear predictors of prostate cancer progression leads to subjective decision-making regarding courses of treatment. The identification of new biomarkers that are predictive of recurrence after radical prostatectomy would advance the field of prostate cancer treatment. Disclosed are miRNAs that can be used as molecular biomarkers to detect or predict the progression of prostate cancer and to adjust a treatment plan accordingly. Furthermore, kits are included for the detection of these miRNAs.

First claim

What is claimed is:

1. A method for treating a subject based on a high biochemical recurrence risk score following post-prostatectomy salvage radiation therapy, comprising
a) determining a miRNA expression profile from a sample from the subject of at least 1 miRNA selected from the group consisting of hsa-miR-628-3p, hsa-miR-1193, hsa-miR-601, hsa-miR-4516, hsa-miR-320e, hsa-miR-508-3p, hsa-miR-598, hsa-miR-626, hsa-miR-563; and
b) calculating a-miRNA-based recurrence risk score from the miRNA expression profile; wherein a high recurrence risk score when compared to Gleason score and lymph node status alone, wherein a high recurrence risk score is based on a regression value of about 0.5 or greater, is an indication of biochemical recurrence within 1 to 5 years; and
c) treating the subject with a high recurrence risk score with adjuvant therapy, radiation therapy, palliative care, or a combination thereof.

2. The method of claim 1 , wherein the at least 1 miRNA comprises miR-4516, miR-601, or a combination thereof.

3. The method of claim 1 , wherein the adjuvant therapy comprises chemotherapy, hormone therapy, biologic therapy, radiation therapy, or a combination thereof.

4. The method of claim 1 , wherein the salvage radiation therapy comprises external beam radiation therapy or internal radiation therapy.

5. The method of claim 1 , wherein the sample is a tumor or a bodily fluid.

6. The method of claim 1 , further comprising grading a tumor according to a Gleason score, and using the Gleason score as a covariate in calculating the recurrence risk score.

7. The method of claim 1 , further comprising determining one or more properties of a tumor including the subject's age, PSA levels, lymph node classification (pN), pathologic tumor classification (pT), resection status, D'Amico classification, and/or Stephenson nomograms and using the one or more properties as covariates in calculating the recurrence risk score.

Assignees

• Ohio State Innovation Foundation
• Univ Of Freiburg

Inventors

• Chakravarti Arnab
• Mckenzie Bell Erica
• Kirste Simon
• Grosu Anca-Ligia

Classifications

• C12Q2600/178

  miRNA, siRNA or ncRNA · CPC title

• C12Q2600/118

  Prognosis of disease development · CPC title

• C12Q1/6886 Primary

  for cancer (immunoassay for cancer G01N33/575) · CPC title

• C12Q2600/106

  Pharmacogenomics, i.e. genetic variability in individual responses to drugs and drug metabolism · CPC title

• C12Q2600/158

  Expression markers · CPC title