Safety and morbidity of first and repeat transrectal ultrasound guided prostate needle biopsies: Results of a prospective European prostate cancer detection study

Purpose: We prospectively evaluate the safety, morbidity and complication r ates for first and repeat transrectal ultrasound guided prostate needle bio psies. Materials and Methods: In this prospective European Prostate Cancer Detecti on Study 1,051 men, with total prostate specific antigen between 4 and 10 n g./ml., underwent transrectal ultrasound guided sextant biopsy plus 2 addit ional transition zone biopsies. Biopsy samples were also obtained from susp icious areas identified during transrectal ultrasound and digital rectal ex amination. All 820 patients with biopsy samples negative for prostate cance r underwent re-biopsy after 6 weeks. Immediate and delayed (range 1 to 7 da ys) morbidity, patient satisfaction and complication rates were recorded. Results: Of the 1,051 subjects the initial biopsy was positive for prostate cancer in 231 and negative, including benign prostatic hyperplasia or beni gn tissue, in 820. Of these 820 patients prostate cancer was detected in 10 % (83) on re-biopsy. Minor or no discomfort was observed in 92% and 89% of patients at first and re-biopsy, respectively (p = 0.29). Immediate morbidi ty was minor and included rectal bleeding (2.1% versus 2.4%, p = 0.13), mil d hematuria (62% versus 57%, p = 0.06), severe hematuria (0.7% versus 0.5%, p = 0.09) and moderate to severe vasovagal episodes (2.8% versus 1.4%, res pectively, p = 0.03). Delayed morbidity of first and re-biopsy was comprise d of fever (2.9% versus 2.3%, p = 0.08), hematospermia (9.8% versus 10.2%, p = 0.1), recurrent mild hematuria (15.9% versus 16.6%, p = 0.06), persiste nt dysuria (7.2% versus 6.8%, p = 0.12) and urinary tract infection (10.9% versus 11.3%, respectively, p = 0.07). Major complications were rare and in cluded urosepsis (0.1% versus 0%) and rectal bleeding that required interve ntion (0% versus 0.1%, respectively). Furthermore, an age dependent pattern of pain apprehension during biopsy was observed with the highest scores in patients younger than 60 years. Conclusions: Transrectal ultrasound guided biopsy is generally well tolerat ed with minor morbidity only rarely requiring treatment. Re-biopsy can be p erformed 6 weeks later with no significant difference in pain or morbidity. Patients younger than 60 years should be counseled in regard to a higher l evel of discomfort, and local and topical anesthesia if desired.