Prospective evaluation of prostate specific antigen (PSA), PSA density, free-to-total PSA ratio and a new formula (prostate malignancy index) for detecting prostate cancer and preventing negative biopsies in patients with normal rectal examinations and intermediate PSA levels

To improve the specificity and sensitivity of prostatic cancer detection, we prospectively evaluated total prostate specific antigen (PSA) level, PSA density, free-to-total PSA ratio and a new formula called prostate malignancy index (PMI) as a discriminator of prostate cancer in patients with inter...

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Published in:International urology and nephrology 1999, Vol.31 (4), p.497-509
Main Authors: Dinçel, C, Caşkurlu, T, Taşçi, A I, Cek, M, Sevin, G, Fazlioğlu, A
Format: Article
Language:English
Subjects:
Adult
Aged
Biomarkers, Tumor - blood
Biopsy, Needle
Diagnosis, Differential
Endosonography
Humans
Male
Middle Aged
Palpation
Predictive Value of Tests
Prospective Studies
Prostate-Specific Antigen - blood
Prostatic Neoplasms - blood
Prostatic Neoplasms - diagnostic imaging
Prostatic Neoplasms - pathology
Rectum - diagnostic imaging
ROC Curve
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container_issue 4
container_start_page 497
container_title International urology and nephrology
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creator Dinçel, C
Caşkurlu, T
Taşçi, A I
Cek, M
Sevin, G
Fazlioğlu, A
description To improve the specificity and sensitivity of prostatic cancer detection, we prospectively evaluated total prostate specific antigen (PSA) level, PSA density, free-to-total PSA ratio and a new formula called prostate malignancy index (PMI) as a discriminator of prostate cancer in patients with intermediate PSA levels and normal digital rectal examinations. Between November 1995 and October 1997, 95 patients who had serum PSA levels of 4.0 to 10.0 ng/ml with normal digital rectal examinations were prospectively evaluated. All patients underwent one or two times transrectal ultrasound guided prostate biopsies. Based on age specific reference range of PSA, PSA density and % free PSA ratio, PMI was calculated for each patient. The free and total serum PSA concentrations were determined by an Immulite assay system. (Diagnostic Product Corp., Los Angeles, California). Overall 20 of 95 (21%) patients had prostate cancer. There were no significant differences in patient mean age and mean total PSA between those with benign and those with malignant biopsies (p>0.05). However, there were significant differences in mean PSAD, mean free-to-total PSA ratio and mean PMI (p
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Between November 1995 and October 1997, 95 patients who had serum PSA levels of 4.0 to 10.0 ng/ml with normal digital rectal examinations were prospectively evaluated. All patients underwent one or two times transrectal ultrasound guided prostate biopsies. Based on age specific reference range of PSA, PSA density and % free PSA ratio, PMI was calculated for each patient. The free and total serum PSA concentrations were determined by an Immulite assay system. (Diagnostic Product Corp., Los Angeles, California). Overall 20 of 95 (21%) patients had prostate cancer. There were no significant differences in patient mean age and mean total PSA between those with benign and those with malignant biopsies (p&gt;0.05). However, there were significant differences in mean PSAD, mean free-to-total PSA ratio and mean PMI (p&lt;0.01, p&lt;0.05, p&lt;0.01, respectively). Benign condition specificities for PM index, percent free PSA, PSA density and total PSA at a 90% sensitivity for prostate cancer were 48%, 10.6%, 8% and 4%, respectively. Of 95 patients, 27 (28.4%) had a PMI of equal or more than 3.1, including 12 of 75 (16%) with negative biopsy and 15 of 20 (75%) with positive biopsy. Furthermore a cutoff MI 0.86 P correctly identified 24% of benign cases without missing any prostate cancer cases. The comparison of receiver operating characteristic (ROC) curve areas showed that PMI was better than total PSA (p&lt;0.01). Although, the area under the ROC curve of % free PSA and PSAD were higher than the area of total PSA, these differences were not statistically significant (p&gt;0.05). We concluded that the prostate malignancy index could be utilized to differentiate benign conditions from prostate cancer in patients with intermediate PSA levels and normal digital rectal examination. 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Benign condition specificities for PM index, percent free PSA, PSA density and total PSA at a 90% sensitivity for prostate cancer were 48%, 10.6%, 8% and 4%, respectively. Of 95 patients, 27 (28.4%) had a PMI of equal or more than 3.1, including 12 of 75 (16%) with negative biopsy and 15 of 20 (75%) with positive biopsy. Furthermore a cutoff MI 0.86 P correctly identified 24% of benign cases without missing any prostate cancer cases. The comparison of receiver operating characteristic (ROC) curve areas showed that PMI was better than total PSA (p&lt;0.01). Although, the area under the ROC curve of % free PSA and PSAD were higher than the area of total PSA, these differences were not statistically significant (p&gt;0.05). We concluded that the prostate malignancy index could be utilized to differentiate benign conditions from prostate cancer in patients with intermediate PSA levels and normal digital rectal examination. Also significant numbers of negative biopsies can be prevented in these patients.</abstract><cop>Netherlands</cop><pub>Springer Nature B.V</pub><pmid>10668945</pmid><doi>10.1023/A:1007167328877</doi><tpages>13</tpages></addata></record>
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ispartof International urology and nephrology, 1999, Vol.31 (4), p.497-509
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subjects Adult
Aged
Biomarkers, Tumor - blood
Biopsy, Needle
Diagnosis, Differential
Endosonography
Humans
Male
Middle Aged
Palpation
Predictive Value of Tests
Prospective Studies
Prostate-Specific Antigen - blood
Prostatic Neoplasms - blood
Prostatic Neoplasms - diagnostic imaging
Prostatic Neoplasms - pathology
Rectum - diagnostic imaging
ROC Curve
title Prospective evaluation of prostate specific antigen (PSA), PSA density, free-to-total PSA ratio and a new formula (prostate malignancy index) for detecting prostate cancer and preventing negative biopsies in patients with normal rectal examinations and intermediate PSA levels
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