mRNA ratios in urinary sediments and/or urine as a prognostic and/or theranostic marker for prostate cancer
First Claim
1. A method for prognosing prostate cancer in a patient comprising:
- a) assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of PSA in a biological sample from said patient, wherein an amplification reaction is used for assessing the amount of said prostate cancer specific PCA3 mRNA;
b) determining a ratio value of said amount of said prostate cancer specific PCA3 mRNA over said amount of PSA; and
c) comparing said ratio value to at least one predetermined cut-off value,wherein a ratio value above said predetermined cut-off value is indicative of a higher risk of mortality of prostate cancer as compared to a ratio value below said predetermined cut-off value.
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Abstract
Described herein are methods and kits for prognosis of prostate cancer in a subject. The methods comprises: (a) determining the ratio of PCA3 and PSA expression in a urine sample and (b) correlating the value of the PCA3/PSA ratio with the aggressiveness and mortality risk of prostate cancer in the subject. Kits for prognosing prostate cancer are also described. More particularly, the present invention features a method for prognosing prostate cancer in a biological sample of a patient comprising: assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of PSA in the biological sample; determining a ratio value of this amount of prostate cancer specific PCA3 mRNA over the amount of PSA; comparing the ratio value to at least one predetermined cut-off value, wherein a ratio value above the predetermined cut-off value is indicative of a higher risk of mortality of prostate cancer as compared to a ratio value below the predetermined cut-off value.
86 Citations
22 Claims
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1. A method for prognosing prostate cancer in a patient comprising:
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a) assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of PSA in a biological sample from said patient, wherein an amplification reaction is used for assessing the amount of said prostate cancer specific PCA3 mRNA; b) determining a ratio value of said amount of said prostate cancer specific PCA3 mRNA over said amount of PSA; and c) comparing said ratio value to at least one predetermined cut-off value, wherein a ratio value above said predetermined cut-off value is indicative of a higher risk of mortality of prostate cancer as compared to a ratio value below said predetermined cut-off value. - View Dependent Claims (2, 3, 4, 9, 11, 12, 13, 14, 16, 17, 22)
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5. A method for prognosing prostate cancer in a patient comprising:
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a) contacting a biological sample from said patient with at least one oligonucleotide that hybridizes to a prostate cancer specific PCA3 mRNA; b) contacting said biological sample with at least one oligonucleotide that hybridizes to a PSA mRNA; c) determining the amount of PCA3 mRNA and the amount of PSA mRNA present in said biological sample; d) determining a ratio value of said amount of PCA3 mRNA over said amount of PSA mRNA; e) comparing said ratio value of said amount of PCA3 mRNA over said amount of PSA mRNA to at least one predetermined cut-off value, wherein a ratio value above said predetermined cut-off value is indicative of the presence of a more aggressive cancer as compared to a ratio value below said predetermined cut-off value which is indicative of the presence of a less aggressive cancer. - View Dependent Claims (10)
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6. A method for assessing prostate cancer tumor volume in a patient comprising:
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a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in a biological sample from said patient, wherein an amplification reaction is used for assessing the amount of said prostate cancer specific PCA3 nucleic acid; b) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of PSA; c) comparing said ratio value to at least one predetermined cut-off value, wherein a ratio value above said predetermined cut-off value is indicative of a greater prostate cancer tumor volume as compared to a ratio value below said predetermined cut-off value.
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7. A method for monitoring prostate cancer tumor growth in a patient comprising:
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a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in a biological sample from said patient at a first point in time, wherein an amplification reaction is used for assessing the amount of said prostate cancer specific PCA3 nucleic acid; b) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of PSA; c) repeating steps a) and b) using a biological sample from said patient at a subsequent point in time; and d) comparing the ratio value obtained in step b) with the ratio value obtained in step c) wherein a higher ratio value in step b) compared to the ratio value obtained in step c) is indicative of the progression of prostate cancer and of a greater tumor volume. - View Dependent Claims (19, 21)
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8. A method for monitoring the progression of prostate cancer in a patient comprising:
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a) contacting a biological sample from said patient with at least one oligonucleotide that hybridizes to a prostate cancer specific PCA3 nucleic acid; b) contacting said biological sample with at least one oligonucleotide that hybridizes to a PSA nucleic acid; c) determining the amount of PCA3 nucleic acid and the amount of PSA nucleic acid present in said biological sample; d) determining a ratio value of said amount of PCA3 nucleic acid over said amount of PSA nucleic acid; and e) repeating steps a) to d) using a biological sample obtained from said patient at a subsequent point in time; and f) comparing the ratio value obtained in step d) with the ratio value obtained in step e) wherein a higher ratio value in step e) compared to the ratio value obtained in step d) is indicative of the progression of prostate cancer.
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15. A method for determining the risk of progression of prostate cancer after therapy comprising:
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a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in a biological sample from a patient before therapy, wherein an amplification reaction is used for assessing the amount of said prostate cancer specific PCA3 nucleic acid; b) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of PSA; c) repeating steps a) and b) using a biological sample from said patient after said therapy; and d) comparing the ratio value obtained after therapy with the ratio value obtained before therapy, wherein a higher ratio value in said sample after therapy compared to the ratio value obtained before therapy is indicative of the progression of prostate cancer.
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18. A method for staging prostate cancer in a patient comprising:
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a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in a biological sample from said patient, wherein an amplification reaction is used for assessing the amount of said prostate cancer specific PCA3 nucleic acid; b) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of PSA; c) comparing said ratio value with at least one predetermined cut-off value; and d) correlating said ratio value with a particular stage of prostate cancer, wherein a ratio value above said predetermined cut-off value indicates a more advanced stage of prostate cancer as compared to a ratio value below said predetermined cut-off value, thereby staging prostate cancer.
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20. A method for prognosing prostate cancer in a human patient, comprising:
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a) performing an in vitro nucleic acid amplification assay on a biological sample from said patient or extract thereof using a first primer pair which is specific to a prostate cancer specific PCA3 nucleic acid sequence and a second primer pair which is specific to a PSA nucleic acid sequence; b) quantifying said PCA3 nucleic acid sequence and said PSA nucleic acid sequence; and c) calculating a normalized ratio of PCA3 over PSA, wherein said ratio can be correlated to a PCA3 mRNA level and a PSA mRNA level in said patient, wherein said normalized ratio of PCA3 over PSA positively correlates with a grade or stage of prostate cancer.
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Specification