Abstract
Background: We conducted a multicenter trial in patients with prostate specific antigen (PSA) levels from 2 to 10 ng/ml to validate the recently presented Vienna Nomogram developed to define the optimal number of biopsy cores required for prostate cancer detection based on PSA, patient age and prostate volume. This should optimize not only cancer detection but also eliminate the need for repeat biopsies. The Nomogram was employed and compared to a matched group of patients undergoing a standard octant biopsy protocol.
Methods: A total of 1,337 patients were prospectively evaluated: 767 underwent standard transrectal ultrasound-guided needle sextant and two transition zone biopsies of the prostate (standard protocol). Patients with benign disease on initial biopsy underwent repeat biopsies within 1 to 2 months. A total of 570 patients underwent prostate biopsy using the Vienna Nomogram. Uni- and multivariate statistical analysis using SAS (Cary, North Carolina) and ROC curves were used to compare both techniques. In addition morbidity was evaluated as defined by early and delayed morbidity on the basis of a patient-based questionnaire and registered morbidity at follow up.
Results: Of the 1,337 patients in the standard group, (31.4%) had prostate cancer (Pca): 22.4% on first and 8.0% on repeat biopsy. In comparison, cancer detection using the Vienna Nomogram was 40.2% after the first set of biopsies, which was significantly superior (p = 0.002) to the octant biopsy technique and even superior to a combination of first and repeat biopsy. Using the cumulative logistic plot analysis the probability of a positive first/repeat biopsy was analyzed. Morbidity was significantly lower in the Vienna Nomogram group as compared to the first + repeat biopsy protocol.
Conclusions: The Vienna Nomogram is an easy tool for selecting the optimal number of prostate biopsy cores based on patient age, PSA and volume. This may solve the problem of optimizing biopsy core numbers. Cancer detection is significantly improved and repeat biopsies may thus become unnecessary. Early and delayed morbidity is also significantly reduced suggesting an advantage not only in terms of improved cancer detection and economics but also in patient acceptance and morbidity.
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