IMPACT OF TRANSRECTAL ULTRASOUND GUIDED PROSTATE BIOPSY ON QUALITY OF LIFE: A PROSPECTIVE RANDOMIZED TRIAL COMPARING 6 VERSUS 12 CORES

Abstract

Recent studies advocating an increase in the number of cores of sextant transrectal ultrasound guided biopsy of the prostate to improve the cancer detection rate often have not addressed the impact on quality of life. We performed a prospective randomized trial comparing 6 to 12 prostate biopsy cores to determine the impact on the cancer detection rate, pain and morbidity, and quality of life. We report the impact on health related and screening specific quality of life in men undergoing 6 versus 12 core transrectal ultrasound guided prostate biopsy. We prospectively randomized 244 men with a mean age plus or minus standard deviation of 65 +/- 8 years, serum total prostate specific antigen between 2.5 and 20.0 ng./ml., and/or digital rectal examination findings suspicious of cancer to undergo 6 or 12 core peripheral zone tissue biopsy. Of the men 71 (29%) were black. All patients completed a self-administered questionnaire before, and 2 questionnaires 2 and 4 weeks after the procedure. Health related quality of life was measured using 2 subscales (emotional well-being and role limitation due to physical health) of the short form 36-Item Health Survey. Screening specific quality of life was addressed by questions on the functional consequences of the procedure (return to daily activity, work-employment and sports-exercise). Health related and screening specific quality of life responses were compared in the groups. After controlling for cancer diagnosis, patient age, race, education, report of pain and baseline emotional well-being there was no significant difference in the mean change in emotional well-being scores at 2 and 4 weeks in the 6 and 12 core groups (p = 0.7 and 0.3, respectively). Similarly after controlling for these factors and baseline role limitation due to physical health there was no significant difference in the mean change in role limitation due to physical health scores at 2 and 4 weeks in the 2 groups (p = 0.3 and 0.5, respectively). There was no difference in the percent of men returning to routine daily activity (p = 0.6), work-employment (p = 0.5) or sports-exercise (p = 0.3) at 0 to 1, 2 to 3 and 4 to 7 days or longer than 1 week after the procedure in the groups. Doubling the sextant biopsy does not affect the quality of life in regard to emotional well-being, role limitation due to physical health, or return to routine daily activity, work-employment or sports-exercise.