Efectividad en el diagnóstico de cáncer de próstata de dos esquemas de biopsia transrectal ecodirigida: Estudio aletorizado

objective: to determine whether a 10-core prostate biopsy scheme is superior to the sextant scheme in diagnosing prostate cancer in patients programmed for a first biopsy, with negative rectal digital examination and psa between 3.5-20 ng/ml. methods: a randomized prospective study was performed comparing two prostate biopsy schemes, with randomization stratification according to prostate volume (< 50 ml and > 50 ml). sample size predetermination yielded a minimum of 304 patients in order to achieve the primary objective. statistical analysis was carried out on an intent-to-treat basis, using the chi-squared test and uni- and multivariate analysis via logistic regression. results: cancer was detected in 27.3% of the cases. a significant association was observed between cancer diagnosis and age (p=0.03), prostate volume (p=0.0001) and ultrasound nodule identification (p=0.0001). no correlation was observed with the total number of cores in the series (p=0.37) or with prostate volume < 50 ml (p=0.87) or > 50 ml (p=0.09). in the multivariate analysis, age > 70 years (p=0.005), prostate volume < 50 ml (p=0.001), and ultrasound nodule identification (p=0.003) were identified as independent variables associated to cancer diagnosis. conclusion: no statistically significant differences were found between the two prostate biopsy schemes. in glands over 50 ml in size, the sextant scheme may prove to be insufficient.