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) obtaining a biological sample from said patient;
b) determining the amount of a prostate cancer specific PCA3 mRNA and the amount of a prostate-specific marker in said biological sample;
c) determining a ratio value of said amount of said prostate cancer specific PCA3 mRNA over said amount of prostate-specific marker; and
d) 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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Accused Products
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 of a prostate-specific marker expression in a urine sample and (b) correlating the value of the PCA3/prostate-specific marker 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 prostate-specific marker in the biological sample; determining a ratio value of this amount of prostate cancer specific PCA3 mRNA over the amount of prostate-specific marker; 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.
74 Citations
22 Claims
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1. A method for prognosing prostate cancer in a patient comprising:
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a) obtaining a biological sample from said patient; b) determining the amount of a prostate cancer specific PCA3 mRNA and the amount of a prostate-specific marker in said biological sample; c) determining a ratio value of said amount of said prostate cancer specific PCA3 mRNA over said amount of prostate-specific marker; and d) 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, 10, 12, 13, 14, 16, 17, 21, 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 prostate-specific marker mRNA; c) determining the amount of PCA3 mRNA and the amount of prostate-specific marker mRNA present in said biological sample; d) determining a ratio value of said amount of PCA3 mRNA over said amount of prostate-specific marker mRNA; e) comparing said ratio value of said amount of PCA3 mRNA over said amount of prostate specific marker 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 (11)
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6. A method for assessing prostate cancer tumor volume in a patient comprising:
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a) obtaining a biological sample from said patient; b) determining the amount of a prostate cancer specific PCA3 nucleic acid and the amount of a prostate-specific marker in said biological sample; c) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of prostate-specific marker; and d) 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) obtaining biological samples from said patient at a first point in time and a subsequent point in time; b) determining the amount of a prostate cancer specific PCA3 nucleic acid and the amount of a prostate-specific marker in said biological sample obtained at said first point in time; c) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of prostate-specific marker; d) repeating b) and c) using said biological sample obtained at said subsequent point in time; and e) comparing the ratio value obtained in c) with the ratio value obtained in d); wherein a higher ratio value in d) compared to the ratio value obtained in c) is indicative of the progression of prostate cancer and of a greater tumor volume. - View Dependent Claims (19)
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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 prostate-specific marker nucleic acid; c) determining the amount of PCA3 nucleic acid and the amount of prostate-specific marker nucleic acid present in said biological sample; d) determining a ratio value of said amount of PCA3 nucleic acid over said amount of prostate-specific marker nucleic acid; e) repeating a) to d) with a biological sample obtained from said patient at a subsequent point in time; and f) comparing the ratio value obtained in d) with the ratio value obtained in e), wherein a higher ratio value in e) compared to the ratio value obtained in 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 in a patient after therapy comprising:
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a) obtaining biological samples from said patient before and after said therapy; b) determining the amount of a prostate cancer specific PCA3 nucleic acid and the amount of a prostate-specific marker in said biological sample obtained before said therapy; c) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of said prostate-specific marker; d) repeating b) and c) using said biological sample obtained after said therapy; and e) 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) obtaining a biological sample from said patient; b) determining the amount of a prostate cancer specific PCA3 nucleic acid and the amount of a prostate-specific marker in said biological sample; c) determining a ratio value of said amount of said prostate cancer specific PCA3 nucleic acid over said amount of prostate-specific marker; d) comparing said ratio value with at least one predetermined cut-off value; and e) correlating a ratio value with a particular stage of prostate cancer, wherein a ratio value above a 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 in said patient.
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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 prostate-specific marker nucleic acid sequence; b) quantifying said PCA3 nucleic acid sequence and said prostate-specific marker nucleic acid sequence; and c) calculating a normalized ratio of PCA3 over said prostate-specific marker, wherein said ratio can be correlated to a PCA3 mRNA level and a prostate-specific marker mRNA level in said patient, wherein said normalized ratio of PCA3 over said prostate-specific marker positively correlates with a grade or stage of prostate cancer.
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Specification