Repeat biopsy outcomes and change in QOL status at 1 year after active surveillance: Results from a Japanese multicenter prospective study and the PRIAS-JAPAN.

Abstract

e15127 Background: In Japan, two prospective multicenter active surveillance (AS) studies are under investigation. The 1st is a prospective Japanese AS study that has been carried out in favorable risk prostate cancer since 2002. The 2nd is the PRIAS-JAPAN; 30 institutions in Japan have been participating into the Prostate cancer Research International: Active Surveillance (PRIAS) study as the PRIAS-JAPAN since 2010. The objective of this study is to evaluate the outcomes of 1-year after AS including prostate re-biopsy and the change in QOL status using the two Japanese prospective cohorts. Methods: 134 patients with biopsy proven favorable risk prostate cancer were enrolled into study between January 2002 and December 2003. Triggers to start curable treatment were PSADT of 2 years or shorter or pathological progression at 1-year re-biopsy. AS remaining rate in 33.2% (median observation period: 78 months). On the other hand, PRIAS-JAPAN study was started since January 2010. Until December 2011, 189 patients were enrolled. 1-year after re-biopsy was recommended to all participants and QOL was assessed at enrollment and at 1-year after AS in both studies with Japanese version SF-36 and SF-8 respectively. Results: In the Japanese AS study, 64 patients who underwent re-biopsy, 42 met the pathological selection criteria again. Reclassification rate was 34.4%. In PRIAS-JAPAN, reclassification rate was 28% (p=0.467). There was no predictive parameter for reclassification in the Japanese AS study. On the other hand, number of positive cores was a significant predictive parameter for reclassification in PRIAS-Japan. Almost all domains of QOL at enrollment revealed better QOL than Norm-based Scoring (NBS). At 1-year after AS, there was no significant change and favorable QOL was maintained in both study. Conclusions: Instead of the time difference between the 2 studies was approximately 10 years, reclassification rate for the current AS cohort (PRIAS-J) was comparable or even lower than the former cohort. Health-related QOL of the Japanese patients who opted AS as an initial treatment was better than NBS and it has been maintained 1-year after AS.