[Consensus-based guidelines on prostate biopsy].

Abstract

OBJECTIVE: To develop evidence-based and consensus-based guidelines, helping physicians to take decisions about diagnostic procedures for men wishing to undergo examination for detection of prostate cancer. MATERIAL AND METHODS: A panel of multidisciplinary Italian experts in urology, medical oncology, laboratory medicine, radiotherapy, pathology and methodologists for clinical trial (Mario Negri Institution) grouped together in 2002 to address specific questions relating to clinical controversies in prostate cancer diagnosis. A practitioners feedback survey by means of a questionnaire of 49 items was also conducted in 2003 to assess the great variability in all the aspects relating a prostate biopsy (PB). Experts reviewed relevant evidence, using CeVEAS scale, of the literature from 1966 to December 2004 (Medline, Embase, Cochrane library) before offering the discussion panel proposed guidelines for a given subset of questions. The discussion panel, which consisted of presenters and representatives from medical oncology, forensic medicine, radiotherapy, ethics, biochemistry and family practice medicine, took place on February 12, 2005 in Bologna. The panel deliberated to reach consensus on suggested guidelines. When evidence was insufficient, suggested guidelines represent the opinion of a cross-section of the presenters and discussion panel. RESULTS: Consensus was achieved regarding all the aspects relating PB. The final paper was approved by the jury, the panel of experts and the audience. A standardized guideline, containing a short version for physicians and a standardized patient information booklet, for nation-wide use was developed. In the final document it has been reported as following: Prostatic biopsy (PB) is recommended in all patients with a PSA> = 4.0 ng/ml (2,5 ng/ml in patients with positive family history), abnormal DRE and %FPSA < 10%. PSAD and PSAV are considered controversial predictive factors. Antibiotic prophylaxis with a fluoroquinolone, which can be omitted in cases of transperineal (TP) PB, is mandatory when using a transrectal (TR) approach. It is necessary to start the prophylaxis the day before and continued for 2-3 days after the procedure. Anaesthesia is mandatory in case of TP biopsy and strongly recommended in cases of TR PB (10 cc of periprostatic lidocaine injection rather than intrarectal lidocaine gel). The optimal PB scheme should include more than 6 cores (preferably 10-12 cores) weighted more laterally and apically. PB directed only to the hypoechoic lesion or standard sextant biopsy (Hodge's scheme) are considered obsolete. PB of the transition zone are mandatory only in cases of re-biopsy. A tru-cut needle with a diameter of 18 Fr. is recommended and a sandwich technique for core fixation informalin is considered the optimal approach. A PB should be repeated within 6-12 months in the following cases:1) First biopsy is inadequate (less than 6 cores, absence of prostatic cells on the cores), 2) in presence of HGPIN, ASAP or both on first PB, 3) in cases with persistently high levels of PSA (PSA > 10 ng/ml or PSA velocity > 0,75 ng/ml/year). PB after radiotherapy is not routinely indicated as well as biopsy of the vesico-urethral anastomosis after radical prostatectomy in patients with PSA failure. CONCLUSIONS: The suggested guidelines represent a reasonable diagnostic approach in patients to be submitted to PB, with the understanding that new data, subsequent findings, or other methodological considerations may lead to future modifications.