Methods for detecting aggressive prostate cancer

A method of treating aggressive prostate cancer in a test subject comprising:

• (a) having obtained an analyte level for one or more analytes in the test subject's biological sample, and having obtained a measurement of one or more clinical variables from the test subject;
• and
• (b) applying a suitable algorithm and/or transformation to a combination of the clinical variable measurements and analyte level/s of the test subject to thereby generate a test subject score value for comparison to a threshold value;
• and
• (c) determining whether the test subject is likely to have aggressive CaP by comparison of the subject test score value and the threshold value,
• wherein:
• the one or more analyte/s comprise or consist of WAP four-disulfide core domain protein 2 (WFDC2 (HE4)), and optionally total prostate surface antigen (PSA),
• the one or more clinical variables comprise at least one of:
• % Free PSA, Free PSA, DRE, Prostate Volume (PV), PIRADs score, Age, Family History (FH) and
• the threshold value was determined by:
• measuring said one or more analyte/s in a series of biological samples obtained from a population of subjects having aggressive CaP and from a population of control subjects not having aggressive CaP, to thereby obtain an analyte level for each said analyte in each said biological sample of the series;
• combining each said analyte level of the series with measurements of said one or more clinical variables obtained from each said subject of the populations, in a manner that allows discrimination between aggressive CaP and an absence of aggressive CaP, to thereby generate the threshold value,
• wherein the method further comprises:
• (i) obtaining a biopsy from the test subject to confirm the presence of aggressive CaP;
• and
• (ii) treating the test subject confirmed to have aggressive CaP, preferably with one or more of surgery (e.g., radical prostatectomy), chemotherapy, radiation therapy (e.g., external beam radiation therapy or brachytherapy (with or without concomitant androgen deprivation therapy)), immunotherapy, hormone therapy, drug treatment or combinations thereof.