Comparison between PSA density, free PSA percentage and PSA density in the transition zone in the detection of prostate cancer in patients with serum PSA between 4 and 10 ng/ml

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Abstract

OBJECTIVE: Compare the capacity of the PSA density (PSAD), Free PSA percentage (%FPSA) and PSA transition zone density (PSATZ) in improving the sensitivity and specificity of the PSA to detect prostate cancer (PCa) in men with a PSA between 4 and 10 ng/mL. MATERIALS AND METHODS: One hundred and forty five men with PSA between 4 and 10 ng/mL were prospectively studied. Blood collection for the total PSA and free PSA was performed as well as transrectal ultra-sound with prostate biopsy and measurement of the total prostate volume (TPV) and transition zone volume (TZV). Patients with initial negative biopsy were followed and the prostate biopsy was repeated in those that presented PSA increase. The capacity of the PSAD, %FPSA and PSADTZ in improving the sensitivity and specificity pf the PSA test to the detection of the PCa was assessed by univariate and multivariate analyses and through the ROC curve. RESULTS: Of the 145 patients, 38 (26.2%) had PCa and in 107 (73.8%) a benign prostate disease was diagnosed. No difference among the PSAD, %FPSA and PSADTZ was found. The multivariate analysis showed that the PSADTZ, %FPSA, TZV and age were those more powerful and highly significant PCa predictors. CONCLUSION:The determination of %FPSA and PSAD can allow a better discrimination between PCa and benign disease that the isolated use of PSA. The combination of PSADTZ, %FPSA, TZV and age promote a high accuracy for PCa detection.

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A method of comparing the areas under receiver operating characteristic curves derived from the same cases.

J A Hanley, B J McNeil, Marnix van Holsbeeck (1983)

Receiver operating characteristic (ROC) curves are used to describe and compare the performance of diagnostic technology and diagnostic algorithms. This paper refines the statistical comparison of the areas under two ROC curves derived from the same set of patients by taking into account the correlation between the areas that is induced by the paired nature of the data. The correspondence between the area under an ROC curve and the Wilcoxon statistic is used and underlying Gaussian distributions (binormal) are assumed to provide a table that converts the observed correlations in paired ratings of images into a correlation between the two ROC areas. This between-area correlation can be used to reduce the standard error (uncertainty) about the observed difference in areas. This correction for pairing, analogous to that used in the paired t-test, can produce a considerable increase in the statistical sensitivity (power) of the comparison. For studies involving multiple readers, this method provides a measure of a component of the sampling variation that is otherwise difficult to obtain.

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Comparison of digital rectal examination and serum prostate specific antigen in the early detection of prostate cancer: results of a multicenter clinical trial of 6,630 men.

W Catalona, J Richie, F Ahmann … (1994)

To compare the efficacy of digital rectal examination and serum prostate specific antigen (PSA) in the early detection of prostate cancer, we conducted a prospective clinical trial at 6 university centers of 6,630 male volunteers 50 years old or older who underwent PSA determination (Hybritech Tandem-E or Tandem-R assays) and digital rectal examination. Quadrant biopsies were performed if the PSA level was greater than 4 micrograms/l or digital rectal examination was suspicious, even if transrectal ultrasonography revealed no areas suspicious for cancer. The results showed that 15% of the men had a PSA level of greater than 4 micrograms/l, 15% had a suspicious digital rectal examination and 26% had suspicious findings on either or both tests. Of 1,167 biopsies performed cancer was detected in 264. PSA detected significantly more tumors (82%, 216 of 264 cancers) than digital rectal examination (55%, 146 of 264, p = 0.001). The cancer detection rate was 3.2% for digital rectal examination, 4.6% for PSA and 5.8% for the 2 methods combined. Positive predictive value was 32% for PSA and 21% for digital rectal examination. Of 160 patients who underwent radical prostatectomy and pathological staging 114 (71%) had organ confined cancer: PSA detected 85 (75%) and digital rectal examination detected 64 (56%, p = 0.003). Use of the 2 methods in combination increased detection of organ confined disease by 78% (50 of 64 cases) over digital rectal examination alone. If the performance of a biopsy would have required suspicious transrectal ultrasonography findings, nearly 40% of the tumors would have been missed. We conclude that the use of PSA in conjunction with digital rectal examination enhances early prostate cancer detection. Prostatic biopsy should be considered if either the PSA level is greater than 4 micrograms/l or digital rectal examination is suspicious for cancer, even in the absence of abnormal transrectal ultrasonography findings.