OBJECTIVE: To examine mortality and morbidity after prostate biopsy in the intervention arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening (PLCO) trial. SUBJECTS AND METHODS: Abstractors from the PLCO trial recorded the types and dates of diagnostic follow-up procedures after positive screens and documented the types and dates of resultant complications. Cancers and deaths among the participants were tracked. The mortality rate in the 120-day period after prostate biopsy was compared with a control rate of deaths in the 120-day period after a negative screen in men without biopsy. Multivariate analysis was performed to control for potential confounders, including age, comorbidities and smoking. Rates of any complication, infectious and non-infectious complications were computed among men with a negative biopsy. Multivariate analysis was used to examine the risk factors for complications. RESULTS: Of the 37,345 men enrolled in the PLCO trial (intervention arm), 4861 had at least one biopsy after a positive screen and 28,661 had a negative screen and no biopsy. The 120-day mortality rate after biopsy was 0.95 (per 1000), compared with the control group rate of 1.8; the multivariate relative risk was 0.49 (95% CI: 0.2-1.1). Among 3706 negative biopsies, the rates (per 1000) of any complication, infectious and non-infections complications were 20.2, 7.8 and 13.0, respectively. A history of prostate enlargement or inflammation was significantly associated with higher rates of both infectious (odds ratio [OR] = 3.7) and non-infectious (OR = 2.2) complications. Black race was associated with a higher infectious complications rate (OR = 7.1) and repeat biopsy was associated with lower rates of non-infectious complications (OR = 0.3). CONCLUSION:Mortality rates were not found to be higher after prostate biopsy in the PLCO trial and complications were relatively infrequent, with several risk factors identified. Published 2013. This article has been contributed to by US Government employees and their work is in the public domain in the USA. BJU International
RCT Entities:
OBJECTIVE: To examine mortality and morbidity after prostate biopsy in the intervention arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening (PLCO) trial. SUBJECTS AND METHODS: Abstractors from the PLCO trial recorded the types and dates of diagnostic follow-up procedures after positive screens and documented the types and dates of resultant complications. Cancers and deaths among the participants were tracked. The mortality rate in the 120-day period after prostate biopsy was compared with a control rate of deaths in the 120-day period after a negative screen in men without biopsy. Multivariate analysis was performed to control for potential confounders, including age, comorbidities and smoking. Rates of any complication, infectious and non-infectious complications were computed among men with a negative biopsy. Multivariate analysis was used to examine the risk factors for complications. RESULTS: Of the 37,345 men enrolled in the PLCO trial (intervention arm), 4861 had at least one biopsy after a positive screen and 28,661 had a negative screen and no biopsy. The 120-day mortality rate after biopsy was 0.95 (per 1000), compared with the control group rate of 1.8; the multivariate relative risk was 0.49 (95% CI: 0.2-1.1). Among 3706 negative biopsies, the rates (per 1000) of any complication, infectious and non-infections complications were 20.2, 7.8 and 13.0, respectively. A history of prostate enlargement or inflammation was significantly associated with higher rates of both infectious (odds ratio [OR] = 3.7) and non-infectious (OR = 2.2) complications. Black race was associated with a higher infectious complications rate (OR = 7.1) and repeat biopsy was associated with lower rates of non-infectious complications (OR = 0.3). CONCLUSION: Mortality rates were not found to be higher after prostate biopsy in the PLCO trial and complications were relatively infrequent, with several risk factors identified. Published 2013. This article has been contributed to by US Government employees and their work is in the public domain in the USA. BJU International
Authors: G Igor Pinkhasov; Yu-Kuan Lin; Ricardo Palmerola; Paul Smith; Frank Mahon; Matthew G Kaag; J Edward Dagen; Lewis E Harpster; Carl T Reese; Jay D Raman Journal: BJU Int Date: 2012-02-07 Impact factor: 5.588
Authors: Stacy Loeb; Suzanne van den Heuvel; Xiaoye Zhu; Chris H Bangma; Fritz H Schröder; Monique J Roobol Journal: Eur Urol Date: 2012-01-05 Impact factor: 20.096
Authors: P F Pinsky; A Miller; B S Kramer; T Church; D Reding; P Prorok; E Gelmann; R E Schoen; S Buys; R B Hayes; C D Berg Journal: Am J Epidemiol Date: 2007-01-22 Impact factor: 4.897
Authors: P C Prorok; G L Andriole; R S Bresalier; S S Buys; D Chia; E D Crawford; R Fogel; E P Gelmann; F Gilbert; M A Hasson; R B Hayes; C C Johnson; J S Mandel; A Oberman; B O'Brien; M M Oken; S Rafla; D Reding; W Rutt; J L Weissfeld; L Yokochi; J K Gohagan Journal: Control Clin Trials Date: 2000-12
Authors: Gerald L Andriole; E David Crawford; Robert L Grubb; Saundra S Buys; David Chia; Timothy R Church; Mona N Fouad; Edward P Gelmann; Paul A Kvale; Douglas J Reding; Joel L Weissfeld; Lance A Yokochi; Barbara O'Brien; Jonathan D Clapp; Joshua M Rathmell; Thomas L Riley; Richard B Hayes; Barnett S Kramer; Grant Izmirlian; Anthony B Miller; Paul F Pinsky; Philip C Prorok; John K Gohagan; Christine D Berg Journal: N Engl J Med Date: 2009-03-18 Impact factor: 91.245
Authors: Robert K Nam; Refik Saskin; Yuna Lee; Ying Liu; Calvin Law; Laurence H Klotz; D Andrew Loblaw; John Trachtenberg; Aleksandra Stanimirovic; Andrew E Simor; Arun Seth; David R Urbach; Steven A Narod Journal: J Urol Date: 2010-01-20 Impact factor: 7.450
Authors: Andrea Gallina; Nazareno Suardi; Francesco Montorsi; Umberto Capitanio; Claudio Jeldres; Fred Saad; Markus Graefen; Shahrokh F Shariat; Hugues Widmer; Philippe Arjane; François Péloquin; Paul Perrotte; Pierre I Karakiewicz Journal: Int J Cancer Date: 2008-08-01 Impact factor: 7.396
Authors: Derek J Rosario; J Athene Lane; Chris Metcalfe; Jenny L Donovan; Andy Doble; Louise Goodwin; Michael Davis; James W F Catto; Kerry Avery; David E Neal; Freddie C Hamdy Journal: BMJ Date: 2012-01-09
Authors: William A Sterling; Joseph Weiner; David Schreiber; Komal Mehta; Jeffrey P Weiss Journal: Int Urol Nephrol Date: 2016-08-31 Impact factor: 2.370
Authors: Alex Z Wang; Amir H Lebastchi; Luke P O'Connor; Michael Ahdoot; Sherif Mehralivand; Nitin Yerram; Samir S Taneja; Arvin K George; Rafael Sanchez-Salas; John F Ward; Pilar Laguna; Jean de la Rosette; Peter A Pinto Journal: World J Urol Date: 2021-01-02 Impact factor: 4.226
Authors: Jonathan E Shoag; Christopher Gaffney; Morgan Pantuck; Tianyi Sun; Michael Gorin; Edward Schaeffer; Art Sedrakyan; Andrew Vickers; Jim Hu Journal: Urology Date: 2019-12-30 Impact factor: 2.649