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 biological sample of a patient comprising:
- a) assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of PSA in said biological sample;
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.
1 Assignment
0 Petitions
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 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.
-
Citations
26 Claims
-
1. A method for prognosing prostate cancer in a biological sample of a patient comprising:
-
a) assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of PSA in said biological sample; 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, 10, 12, 13, 14, 15, 18, 19, 25, 26)
-
-
5. A method for prognosing prostate cancer in a biological sample comprising:
-
a) contacting a biological sample 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 (11)
-
-
6. A method for assessing prostate cancer tumor volume in a biological sample comprising:
-
a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in a sample; 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.
-
-
7. A method of monitoring prostate cancer tumor growth in a biological sample of a patient comprising:
-
a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in said biological sample at a first point in time; 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 (21, 23)
-
-
8. A method of monitoring the progression of prostate cancer in a biological sample comprising:
-
a) contacting a biological sample 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) in 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.
-
-
16. A diagnostic and prognostic kit for prostate cancer comprising at least one container means having disposed therein
a) at least one oligonucleotide that hybridizes to a prostate cancer specific PCA3 nucleic acid selected from the group consisting of: -
i. a nucleic acid sequence set forth in SEQ ID NO;
1;ii. a nucleic acid sequence set forth in SEQ ID NO;
2;iii. a nucleic acid sequence fully complementary to i or ii; and iv. a nucleic acid sequence that hybridizes under high stringency condition to the nucleic acid sequence in i, ii or iii; b) at least one oligonucleotide that hybridizes to a PSA nucleic acid selected from the group consisting of; i. a nucleic acid sequence set forth in SEQ ID NO;
1;ii. a nucleic acid sequence fully complementary to i; iii. a nucleic acid sequence that hybridizes under high stringency condition to the nucleic acid sequence in i or ii; and c) instructions for determining prostate cancer diagnosis and prognosis based on the detection of a particular ratio of prostate cancer specific PCA3 nucleic acid level over PSA nucleic acid level.
-
-
17. A method of determining the risk of progression of prostate cancer after therapy comprising:
-
a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in a sample before therapy; 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 the 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 said therapy is indicative of the progression of prostate cancer.
-
-
20. A method of staging prostate cancer in a biological sample of a patient comprising:
-
a) assessing the amount of a prostate cancer specific PCA3 nucleic acid and the amount of PSA in said biological sample; 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 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.
-
-
22. A method for prognosing prostate cancer in a human patient, comprising:
-
a) performing an in vitro nucleic acid amplification assay on a biological sample of 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.
-
-
24. A kit for prognosing prostate cancer in a patient comprising:
-
a) a first primer pair specific for amplifying a PCA3 nucleic acid associated with prostate cancer present in a patient sample; b) a second primer pair specific for amplifying a PSA nucleic acid; c) reagents enabling a quantitative detection of PCA3 and of PSA nucleic acid amplification products when said PCA3 and second prostate-specific nucleic acid sequence are present; and d) instructions for determining prostate cancer diagnosis and prognosis based on the detection of a particular ratio of prostate cancer specific PCA3 nucleic acid level over PSA nucleic acid level.
-
Specification