The only available method to detect prostate cancer is prostate biopsy; however, to our knowledge, no evidence-based clinical practice guidelines have been established on this topic.A three-year project was elaborated in which experts in the field worked to define the controversies existing in clinical practice regarding prostatic biopsies and then to develop guidelines by means of a systematic search of all the English-language literature using online databases and a consensus conference.The guidelines were formulated to help practitioners in making clinical decisions regarding the appropriate time the patient should undergo prostate biopsy, the type of antibiotic prophylaxis and anaesthesia, the biopsy approach, the method for processing and reporting prostatic needle cores, the biopsy technique, when to repeat a biopsy after a prior negative biopsy, radiotherapy or radical prostatectomy and the accuracy of biopsies in staging prostate cancer.