Methods and Compositions for Determining Indication for Prostate Biopsy

A method of determining whether to perform a prostate biopsy on a subject, comprising:

• a) determining, from a nucleic acid sample obtained from the subject, a genotype for the subject at a plurality of biallelic polymorphic loci, wherein each of said plurality has an associated allele and an unassociated allele, wherein the genotype is selected from the group consisting of homozygous for the associated allele, heterozygous, and homozygous for the unassociated allele;
• b) calculating a genetic risk score (GRS) for the subject based on the genotype determined in step (a);
• c) analyzing the GRS of the subject in combination with a prostate specific antigen (PSA) level of the subject to identify a prostate cancer detection rate for the subject, whereby a prostate cancer detection rate of greater than or equal to a reference value identifies the subject as a subject for whom a prostate biopsy is indicated;
• d) performing a prostate biopsy on the subject if the subject is identified as a subject for whom a prostate biopsy is indicated according to step (c);
• and
• e) not performing a prostate biopsy on the subject if the subject is not identified as a subject for whom a prostate biopsy is indicated according to step (c).

A method of identifying a subject for whom a prostate biopsy is indicated, comprising:

• a) determining, from a sample obtained from the subject, a p2PSA level, a free PSA (fPSA) level and a total PSA (tPSA) level for the subject;
• b) calculating a prostate health index (PHI) for the subject based on the p2PSA level, fPSA level and tPSA level determined in step (a);
• c) analyzing the PHI of the subject in combination with a prostate specific antigen (PSA) level of the subject to identify a prostate cancer detection rate for the subject, whereby a prostate cancer detection rate of greater than or equal to a reference value identifies the subject as a subject for whom a prostate biopsy is indicated;
• and
• d) performing a prostate biopsy on the subject identified as a subject for whom a prostate biopsy is indicated according to step (c).

A method of determining whether to perform a prostate biopsy on a subject, comprising:

• a) determining, from a sample obtained from the subject, a p2PSA level, a free PSA (fPSA) level and a total PSA (tPSA) level for the subject;
• b) calculating a prostate health index (PHI) for the subject based on the p2PSA level, fPSA level and tPSA level determined in step (a);
• c) analyzing the PHI of the subject in combination with a prostate specific antigen (PSA) level of the subject to identify a prostate cancer detection rate for the subject, whereby a prostate cancer detection rate of greater than or equal to a reference value identifies the subject as a subject for whom a prostate biopsy is indicated;
• d) performing a prostate biopsy on the subject if the subject is identified as a subject for whom a prostate biopsy is indicated according to step (c);
• and
• e) not performing a prostate biopsy on the subject if the subject is not identified as a subject for whom a prostate biopsy is indicated according to step (c).

A chart for determining prostate cancer detection rate as a percentile value, said chart comprising:

• a) a first region comprising a first, second and third prostate specific antigen (PSA) value;
• b) a second region, adjacent to each respective first, second and third PSA value of the first region, comprising a first, second and third genetic risk score (GRS) value and an average detection rate value (ALL), wherein the first, second and third GRS values are the same for each of the respective PSA values to which the first, second and third GRS values are adjacent;
• c) a third region, adjacent to the second region, comprising a reference bar to show a prostate cancer detection rate in percentiles ranging from 1% to 100%;
• and
• d) a fourth region comprising a grid, aligned below the third region and in parallel with the first, second and third GRS values and the ALL value of the second region for each of the respective first, second and third PSA values of the first region, showing a percentile value that specifies a prostate cancer detection rate for each of the first, second and third GRS values and the ALL value in the second region for each of the first, second and third PSA values in the first region.

A chart for determining prostate cancer detection rate as a percentile value, said chart comprising:

• a) a first region comprising a first, second and third prostate specific antigen (PSA) value;
• b) a second region, adjacent to each respective first, second and third PSA value of the first region, comprising a first, second and third prostate health index (PHI) value and an average detection rate value (ALL), wherein the first, second and third PHI values are the same for each of the respective PSA values to which the first, second and third PHI values are adjacent;
• c) a third region, adjacent to the second region, comprising a reference bar to show a prostate cancer detection rate in percentiles ranging from 1% to 100%;
• and
• d) a fourth region comprising a grid, aligned below the third region and in parallel with the first, second and third PHI values and the ALL value of the second region for each of the respective first, second and third PSA values of the first region, showing a percentile value that specifies a prostate cancer detection rate for each of the first, second and third PHI values and the ALL value in the second region for each of the first, second and third PSA values in the first region.