A prospective, randomized trial comparing the Vienna nomogram to an eight-core prostate biopsy protocol.

OBJECTIVE: • To compare prostate cancer detection rates using the Vienna nomogram versus an 8-core prostate biopsy protocol. To compare the complication rates of transrectal prostate biopsy in the two groups. PATIENTS AND METHODS: • In a prospective randomized trial, men with a serum PSA ≥ 2.5 ng/ml were stratified according to serum PSA (I = PSA 2.5-10; II = PSA 10.1-30; III = PSA 30.1-50 ng/mL) and were then randomized to group A (number of cores determined according to the Vienna nomogram) or group B (8-core prostate biopsy). • Statistical analysis was performed using Student's t-test for parametric data, Mann-Whitney test for nonparametric data and Fisher's exact test for contingency tables. A two-tailed p-value <0.05 was accepted as statistically significant.
RESULTS: • In the period July 2006 to July 2009, 303 patients were randomized to group A (n = 152) or group B (n = 151). There were no significant differences in serum PSA, prostate volume, PSA density or post-biopsy complications between the groups. • The cancer detection rate was lower in group A than in group B for the whole study cohort (35.5% vs 38.4%), for those with PSA < 10 ng/ml (28.1% vs 33%) and for those with prostate volume >50 ml (22% vs 25.8%). These differences were not statistically significant (NSS).
CONCLUSION: • These findings suggest that there is no significant advantage in using the Vienna nomogram to determine the number of prostate biopsy cores to be taken, compared to an 8-core biopsy protocol.

RCT Entities:   Population Interventions Outcomes