Predictors for reclassification at repeat biopsy in active surveillance cohort for low-risk prostate cancer: From an interim analysis of PRIAS-JAPAN.

Authors

Mikio Sugimoto

Mikio Sugimoto

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

Organizations

Department of Urology, Kagawa University Faculty of Medicine, Kagawa, Japan, Kagawa University, Kagawa, Japan, Department of Renal and Genitourinary Surgery, Harasanshin Hospital, Fukuoka, Japan, Division of Urology, Harasanshin Hospital, Fukuoka, Japan, Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan, Tohoku University Graduate School of Medicine, Sendai, Japan, Jikei University School of Medicine, Tokyo, Japan, The Jikei University Kashiwa Hospital, Kashiwa-shi, Chiba, Japan, Department of Urology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan

Research Funding

Other

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
AgeMedian70671.053 (1.015-1.093)/
(range)(50-87)(48-84)0.006
PSAD (ng/ml/cc)Median0.1600.1401.748 (1.110-2.751)/
(range)(0.060-0.198)(0.019-0.1995)0.016
Positive core rate (%)Median10.08.331.112 (1.061-1.165)/
(range)(4.55-25.0)(2.38-40.0)0.000
PSADTNeg. or > 10yr461471.426 (1.079-1.883)/
3-10yr42830.013
< 3yr3457

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Abstract Details

Meeting

2017 Genitourinary Cancers Symposium

Session Type

Poster Session

Session Title

Poster Session B: Prostate Cancer and Urothelial Carcinoma

Track

Prostate Cancer,Urothelial Carcinoma,Prostate Cancer

Sub Track

Prostate Cancer - Localized Disease

Clinical Trial Registration Number

UMIN000002874

Citation

J Clin Oncol 35, 2017 (suppl 6S; abstract 118)

DOI

10.1200/JCO.2017.35.6_suppl.118

Abstract #

118

Poster Bd #

B12

Abstract Disclosures

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