Methods for diagnosing benign prostatic diseases and prostatic a

Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...

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436 64, 128630, G01N 33574, G01N 3348, A61B 500

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active

061400653

ABSTRACT:
The present invention relates to novel reflex methods for identifying a male human patient as suitable for diagnosis either benign prostatic diseases (BPD), (such as benign prostatic hyperplasia, prostatitis, or glandular atrophy), or prostatic adenocarcinoma (CAP) without requiring a biopsy. The method requires measuring two biochemical markers and knowing the patient age. The total prostate specific antigen (PSA) level in the blood or serum of the patient is measured. If the patient has a total PSA level of between 4.0 ng/mL and 20.0 ng/mL, then the free PSA level in the blood or serum of the patient is measured. The proportion of free PSA to total PSA is calculated. The patient's age is noted, rounding down to an integral numbers of years. The two measured values and the age are entered into a particular identifying algorithm which is derived from a logistic regression model. If a value of greater than about 0.18 is generated from entering these values into the algorithm, then the patient is diagnosed as having CAP. If value of less than or equal to about 0.18 is generated from entering these values into the algorithm, then the patient is diagnosed as having BPD.

REFERENCES:
patent: 5710007 (1998-01-01), Luderer et al.
Baldalament et al. "An algorithm for predicting nonorgan confined prostate cancer using the results obtained from sextant core biopsies with prostate specificd antigen level" The Journal of Urology. vol. 156. pp. 1375-1380, Oct. 1996.

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