Hybritech Incorporated

Other

Beckman Coulter, Inc.

Baylor College of Medicine

Harry G Rittenhouse

Stephen D Mikolajczyk

Robert L Wolfert

Kevin Slawin

Tang Jang Wang

Mohammad Saeed Saedi

Abhay Kumar

Donald J Tindall

Charles Y F Young

Inactive precursor forms of PSA (pPSA) have been identified to exist in serum and tissues of patients with prostate cancer. Antibodies specific for pPSA are provided. Methods for detecting inactive precursors of PSA in human physiological fluid and tissues are also provided, as well as diagnostic kits and methods useful in the diagnosis and management of prostate cancer.

Forms of prostate specific antigens and methods for their detection

Assays for detecting and determining the presence of prostate cancer is provided. The assays are capable of detecting prostate cancer in the population of men with a significantly higher ratio of free PSA to total PSA. The assays are also capable of detecting prostate cancer in the population of men with a low amount of total PSA, i.e., in the range of 2 to 4 ng/ml. In accordance with one embodiment of the present invention, the assay includes the steps of (a) determining the amount of total PSA contained in a biological sample from the patient, (b) determining the amount of free PSA in the sample; and calculating the ratio of the free PSA to the total PSA, (c) determining the amount of pPSA in the sample, (d) determining the amount of BPSA in the sample, (e) determining the amount of inPSA in the sample, and (f) correlating the amount of inPSA contained in the sample to the presence of prostate cancer in the patient by comparing the amount of inPSA to a predetermined value established with control samples of known cancer and benign disease diagnosis, based on both the level of total PSA and the % free PSA.

Method of analyzing non-complexed forms of prostate specific antigen in a sample to improve prostate cancer detection

A substantially pure and isolated novel form of prostate specific antigen (PSA) is provided. The novel form of PSA of the present invention comprises at least one clip at Lys 182 of the amino acid sequence of a mature form of PSA. Preferably, the novel form of PSA additionally comprises one or more clips at a location selected from a group consisting of Ile 1, Lys 145, and Lys 146. More preferably, the form of PSA contains at least two clips at Lys 145 and Lys 182 of the amino acid sequence of a mature form of PSA. The novel forms of PSA exist at an elevated level in patients suspected of having benign prostatic hyperplasia (BPH) and therefore may be used as a serum mark or an immunohistological marker to help distinguish BPH from prostate cancer. Antibodies recognizing the novel forms of PSA and immunoassays that detect and determine the novel forms of PSA of the present invention in a sample are also provided. Further provided are a kit and a method for detecting the novel forms of PSA for aiding in the differentiation of prostate cancer from BPH.

Forms of prostate specific antigen (PSA) specific for benign prostatic hyperplasia (BPH) and methods of using such

Prostate cancer is detected by determining the presence of hK2 RNA in a physiological sample.

Method for detection of micrometastatic prostate cancer

A method of distinguishing prostate cancer from benign prostatic hyperplasia (BPH) is provided. The mathematical combination or ratio of proPSA and BPSA serum or tissue markers may be used for distinguishing benign prostatic hyperplasia (BPH) from prostate cancer. It is the discovery of the present invention that BPSA is preferentially elevated in transition zone prostate tissue whereas pPSA is elevated in the peripheral zone of prostate tissue. A kit for aiding in distinguishing BPH from prostate cancer is also provided.

Growing community of inventors

Del Mar, CA, United States of America

Harry G Rittenhouse