Should inclusion criteria for active surveillance for low-risk prostate cancer be more stringent? From an interim analysis of PRIAS-JAPAN - Abstract

PURPOSE: To define clinical and pathological factors predicting reclassification at the time of 1-year repeat biopsy (re-Bx) based on a Japanese cohort forming part of the Prostate Research International: Active Surveillance (PRIAS) study.

PATIENTS AND METHODS: The inclusion criteria for the PRIAS study are as follows: clinical stage T1c/T2, PSA ≤ 10 ng/ml, PSA density (PSAD) < 0.2 ng/ml per milliliter, one or two positive biopsy cores, and Gleason score (GS) ≤ 6 at initial diagnostic biopsy. Baseline clinical characteristics and prostate-specific antigen doubling time (PSADT) at the time of re-Bx were analyzed via multivariate logistic regression with respect to reclassification and 'no cancer' status on the 1-year re-Bx.

RESULTS: A total of 386 patients were enrolled in PRIAS-JAPAN by the end of 2013. Of these, 216 underwent re-Bx at 1 year. A total of 73 patients (33.8 %) were reclassified, whereas 74 (34.3 %) had no cancer. Older age, a higher PSAD, a higher positive core rate, and a shorter PSADT were significant predictors of reclassification. The positive core rate was the predictor common to reclassification, no cancer, and high GS, upon re-Bx.

CONCLUSIONS: An interim analysis of a Japanese AS cohort participating in PRIAS revealed that the positive core rate was strongly associated with reclassification at the 1-year re-Bx. However, although amendment of the PRIAS inclusion criteria to incorporate a positive core might reduce any concern about underestimation, this would also reduce the number of patients undergoing AS.

Written by:
Sugimoto M, Hirama H, Yamaguchi A, Koga H, Hashine K, Ninomiya I, Shinohara N, Maruyama S, Egawa S, Sasaki H, Kakehi Y.   Are you the author?
Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan.  

Reference: World J Urol. 2014 Nov 27. Epub ahead of print.
doi: 10.1007/s00345-014-1453-8


PubMed Abstract
PMID: 25428792

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