To report the outcomes of repeat biopsies, metastasis and survival in the Prostate Cancer Research International: Active Surveillance (PRIAS)-JAPAN study, a prospective observational study for Japanese patients, initiated in 2010.
At the beginning, inclusion criteria were initially low-risk patients, prostate-specific antigen (PSA) density (PSAD) <0.2, and ≤2 positive biopsy cores. As from 2014, GS3+4 has also been allowed for patients aged 70 years and over. Since January 2021, the age limit for Gleason score (GS) 3 + 4 cases was removed, and eligibility criteria were expanded to PSA ≤20 ng/mL, PSAD <0.25 nd/mL/cc, unlimited number of positive GS 3 + 3 cores, and positive results for fewer than half of the total number of cores for GS 3 + 4 cases if magnetic resonance imaging fusion biopsy was performed at study enrolment or subsequent follow-up. For patients eligible for active surveillance, PSA tests were performed every 3 months, rectal examination every 6 months, and biopsies at 1, 4, 7 and 10 years, followed by every 5 years thereafter. Patients with confirmed pathological reclassification were recommended for secondary treatments.
As of February 2024, 1302 patients were enrolled in AS; 1274 (98%) met the eligibility criteria. The median (interquartile range) age, PSA level, PSAD, and number of positive cores were 69 (64-73) years, 5.3 (4.5-6.6) ng/mL, 0.15 (0.12-0.17) ng/mL, and 1 (1-2), respectively. The clinical stage was T1c in 1089 patients (86%) and T2 in 185 (15%). The rates of acceptance by patients for the first, second, third and fourth re-biopsies were 83%, 64%, 41% and 22%, respectively. The pathological reclassification rates for the first, second, third and fourth re-biopsies were 29%, 30%, 35% and 25%, respectively. The 1-, 5- and 10-year persistence rates were 77%, 45% and 23%, respectively. Six patients developed metastasis, and one patient died from prostate cancer.
Pathological reclassification was observed in approximately 30% of the patients during biopsy; however, biopsy acceptance rates decreased over time. Although metastasis occurred in six patients, only one death from prostate cancer was recorded.
BJU international. 2024 Jun 17 [Epub ahead of print]
Takuma Kato, Ryuji Matsumoto, Akira Yokomizo, Yoichiro Tohi, Hiroshi Fukuhara, Yoichi Fujii, Keiichiro Mori, Takuma Sato, Junichi Inokuchi, Katsuyoshi Hashine, Shinichi Sakamoto, Hidefumi Kinoshita, Koji Inoue, Toshiki Tanikawa, Takanobu Utsumi, Takayuki Goto, Isao Hara, Hiroshi Okuno, Yoshiyuki Kakehi, Mikio Sugimoto
Department of Urology, Faculty of Medicine, Kagawa University, Kita-gun, Kagawa, Japan., Department of Renal and Genito-Urinary Surgery, Graduate School of Medicine, Hokkaido University, Sapporo, Hokkaido, Japan., Department of Urology, Harasanshin Hospital, Fukuoka, Japan., Department of Urology, Faculty of Medicine, Kyorin University, Tokyo, Japan., Department of Urology, Faculty of Medicine, Tokyo University, Tokyo, Japan., Department of Urology, Jikei University School of Medicine, Tokyo, Japan., Department of Urology, Graduate School of Medicine, Tohoku University, Sendai, Miyagi, Japan., Department of Urology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan., Department of Urology, NHO Shikoku Cancer Center, Matsuyama, Ehime, Japan., Department of Urology, Graduate School of Medicine, Chiba University, Chiba, Japan., Department of Urology, Faculty of Medicine, Kansai Medical University, Osaka, Japan., Department of Urology, Kurashiki Central Hospital, Kurashiki, Okayama, Japan., Department of Urology, Niigata Cancer Center Hospital, Niigata, Japan., Department of Urology, Toho University Sakura Medical Center, Chiba, Japan., Department of Urology, Graduate School of Medicine, Kyoto University, Kyoto, Japan., Department of Urology, Wakayama Medical University, Wakayama, Japan., Department of Urology, Kyoto Medical Center, Kyoto, Japan.