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

World Journal of Urology Aims and scope Submit manuscript

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.

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Acknowledgments

We thank Dr. Tomonori Habuchi, Dr. Takamitsu Inoue, Dr. Tadashi Matsuda, Dr. Hidefumi Kinoshita, Dr. Seiji Naito, Dr. Akira Yokomizo, Dr. Osamu Ogawa, Dr. Tomomi Kamba, Dr. Akito Terai, Dr. Kazuhiro Suzuki, Dr. Kazuto Ito, Dr. Yasuo Kitamura, Dr. Toshihiro Saito, Dr. Taiji Tsukamoto, Dr. Naoya Masumori, Dr. Hiroshi Kitamura, Dr. Tomohiko Ichikawa, Dr. Shinichi Sakamoto, Dr. Toshiro Terachi, Dr. Takeshi Nomoto, Dr. Koichiro Akakura, Dr. Yoshiko Maeda, Dr. Yukio Honma, Dr. Hiroshi Fukuhara, Dr. Hiroyoshi Suzuki, Dr. Naoto Kamiya, Dr. Yoichi Arai, Dr. Koji Mitsuzuka, Dr. Hiro-omi Kanayama, Dr. Tomoharu Fukumori, Dr. Hideki Sakai, Dr. Tsukasa Igawa, Dr. Seiichiro Ozono, Dr. Takayuki Sugiyama, Dr. Akio Matsubara, Dr. Jun Teishima, Dr. Toshiyuki Kamoto, Dr. Hiromasa Tsukino, Dr. Yoshihiko Tomita, Dr. Hisashi Kawazoe, Dr. Hideyasu Matsuyama, Dr. Hiroaki Matsumoto, Dr. Seiichi Saito, Dr. Takuma Oshiro, Dr. Isao Hara, and Dr. Takeshi Inagaki for their great contribution to this study. The authors thank all contributions for PRIAS-JAPAN.

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None.

Ethical standard

This study has been approved by the appropriate ethics committee and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.

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Correspondence to Mikio Sugimoto.

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Sugimoto, M., Hirama, H., Yamaguchi, A. et al. Should inclusion criteria for active surveillance for low-risk prostate cancer be more stringent? From an interim analysis of PRIAS-JAPAN. World J Urol 33, 981–987 (2015). https://doi.org/10.1007/s00345-014-1453-8

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  • DOI: https://doi.org/10.1007/s00345-014-1453-8

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