Patent ID: 8192931

Claim:
A method for determining a predisposition for developing prostate cancer or a presence of prostate cancer in a patient, said method comprising: (a) obtaining a crude urine sample from a patient, said crude urine sample comprising at least one prostate cell or nucleic acid extract thereof; (b) performing an RNA hybridization and/or amplification reaction on mRNA contained in said crude urine sample, using a first oligonucleotide or first primer pair specific to a prostate cancer-specific PCA3 mRNA molecule which is: (i) a polynucleotide molecule comprising the sequence of SEQ ID NO: 9, 10 or 13; (ii) a polynucleotide molecule that hybridizes under high stringency conditions to (i), wherein said high stringency conditions comprise a hybridization at 65° C. in 6×SSC or 5×SSPE, 5× Denhardt's solution, 0.5% SDS and 100 μg/ml denatured carrier DNA and a washing at 65° C. in 0.2×SSC/0.1% SDS; or (iii) a polynucleotide molecule fully complementary to (i) or (ii); (c) performing a second RNA hybridization and/or amplification reaction on mRNA contained in said crude urine sample, using a second oligonucleotide or second primer pair specific to a prostate-specific mRNA molecule; (d) detecting said PCA3 mRNA molecule and said prostate-specific mRNA molecule; and (e) determining, based on the presence or level of said prostate cancer-specific PCA3 mRNA molecule in said crude urine sample, that: (1) said patient has prostate cancer or has a higher risk of developing prostate cancer when an elevated level of said prostate cancer-specific PCA3 mRNA molecule is detected, as compared to a level thereof associated with a normal or non-malignant prostate state; or (2) said patient does not have prostate cancer or has a lower risk of developing prostate cancer when said prostate cancer-specific PCA3 mRNA molecule is not detected or is detected at a lower level, as compared to a level thereof associated with a normal or non-malignant prostate state, and when said prostate-specific mRNA molecule is detected, thereby validating the non detection or lower detection of said PCA3 mRNA molecule.