Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan
Mikio Sugimoto , Yoshiyuki Kakehi , Hiromi Hirama , Seiji Naito , Akito Yamaguchi , Hirofumi Koga , Nobuo Shinohara , Satoru Maruyama , Yoichi Arai , Koji Mitsuzuka , Shin Egawa , Hiroshi Sasaki , Yukio Homma , Hiroshi Fukuhara
Background: The Prostate Cancer Research International: Active Surveillance (PRIAS) study is a large international prospective observational AS study that commenced in 2006. Japan has participated in the study (PRIAS-JAPAN) since 2010, and recruitment remains ongoing. The objective of this study is 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 PRIAS study. 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 on the 1-year re-Bx. Results: A total of 711 patients were enrolled in PRIAS-JAPAN by September 2016. Of these, 409 underwent re-Bx at 1-year. The re-Bx acceptance rate was 83.3%. A total of 122 (29.8%) was reclassified whereas 150 (36.7%) had no cancer. Older age, a higher PSAD, a higher positive core rate, and a shorter PSADT were significant predictors of reclassification. Among them, the positive core rate was the strongest predictor for pathological reclassification at 1-year after starting AS. The AS remaining rates at 1, 2, 3, 4 and 5 years were 93.9%, 70.6%, 65.7%, 60.0% and 49.5% respectively 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. Clinical trial information: UMIN000002874.
Reclassification group (n = 122) | Non-reclassification group (n = 287) | Multivariate analysis OR (95%CI) /p-value | ||
---|---|---|---|---|
Age | Median | 70 | 67 | 1.053 (1.015-1.093)/ |
(range) | (50-87) | (48-84) | 0.006 | |
PSAD (ng/ml/cc) | Median | 0.160 | 0.140 | 1.748 (1.110-2.751)/ |
(range) | (0.060-0.198) | (0.019-0.1995) | 0.016 | |
Positive core rate (%) | Median | 10.0 | 8.33 | 1.112 (1.061-1.165)/ |
(range) | (4.55-25.0) | (2.38-40.0) | 0.000 | |
PSADT | Neg. or > 10yr | 46 | 147 | 1.426 (1.079-1.883)/ |
3-10yr | 42 | 83 | 0.013 | |
< 3yr | 34 | 57 |
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