Described herein are method, compositions and kits for prognosis of prostate cancer. The methods include determining the ratio of PCA3 and of a prostate-specific marker expression in a urine sample and correlating the value of the PCA3/prostate-specific marker ratio with the aggressiveness and mortality risk of prostate cancer in the subject. The method for prognosing prostate cancer in a sample of a patient includes assessing the amount of a prostate cancer specific PCA3 mRNA and the amount of prostate-specific marker in the 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.

The invention provides assay methods of detecting plasma protease CI inhibitor (Cl-INH) that binds plasma kallikrein, Factor XII, or both, and uses thereof for identifying subjects at risk for or suffering from a pKal-mediated or bradykinin-mediated disorder. Provided methods permit analysis of patients with plasma kallikrein-mediated angioedema (KMA), or other diseases mediated by pKal useful in the evaluation and treatment.

Methods and apparatuses for conducting analyses are provided.

The present application provides an agent comprising or consisting of a binding moiety with specificity for a kallikrein protein (for example, PSA or hK2) for use in the treatment of prostate cancer, and a method for the treatment of prostate cancer in a patient, the method comprising the step of administering a therapeutically effective amount of an agent comprising or consisting of a binding moiety with specificity for a kallikrein protein to the patient.

Plasma kallikrein binding proteins and methods of using such proteins are described.

The present invention provides methods that are for acquiring various types of supplementary information used for diagnosis or treatment of prostate cancer, and that can be implemented in a less-invasive manner at a low cost. Provided are, by measuring the content of prostate specific antigen (PSA) having a -N-acetylgalactosamine residue at a non-reducing terminal of a sugar chain in a specimen, and comparing the measured value with a threshold value, (1) a method for estimating whether a Gleason score (primary pattern and secondary pattern) is not less than or less than a prescribed value, (2) a method for estimating whether the pathological stage (pT) is not less than or less than a prescribed value, and (3) a method for acquiring information for assessment indicating diagnosis or treatment should be actively conducted because a GS at gross total removal is expected to be higher than a GS at biopsy.

Aspects of the disclosure relate to improved methods for predicting whether a prostate tissue biopsy obtained from a subject will contain detectable prostate cancer. In some embodiments, the disclosure provides improved prostate antigen standards for quantifying levels of prostate antigens.

The invention provides assay methods of detecting plasma protease CI inhibitor (C1-INH) that binds plasma kallikrein, Factor XII, or both, and uses thereof for identifying subjects at risk for or suffering from a pKal-me-diated or bradykinin-mediated disorder. Provided methods permit analysis of patients with plasma kallikrein-mediated angioedema (KMA), or other diseases mediated by pKal useful in the evaluation and treatment.

A method for indicating a presence or non-presence of a predefined solid tumor cancer in an individual, comprising the steps of: A. Providing at least one biological sample originating from said individual at a first point in time; B. Providing at least one biological sample originating from said individual at a second point in time; C. In said at least two biological samples, measuring a presence or concentration of at least one biomarker related to said predefined solid tumor cancer; D. Combining data regarding the presence or concentration of the at least one biomarker to form a kinetic composite value that reflects the change of biomarker presence or concentration; E. Correlating the kinetic composite value to the presence or non-presence of said predefined solid tumor cancer in said individual by comparing the kinetic composite value to a pre-determined cut-off value established with control samples of known predefined solid tumor cancer and benign disease diagnosis; wherein the time period between the first point in time and the second point in time is in the range from 0.5% to 25%, or more preferably in the range from 0.1% to 15%, of a typical tumor volume doubling time of said predefined solid tumor cancer; and the at least one biomarker determined is the same biomarker in each of the biological samples.

The invention provides novel peptide binders for streptavidin (SA), Taq polymerase and several human proteins: Prostate Specific Antigen (PSA), thrombin, Tumor Necrosis Factor Alpha (TNF), and Urokinase-type Plasminogen Activator (uPA).