Japanese Journal of Clinical Oncology Advance Access originally published online on February 12, 2008
Japanese Journal of Clinical Oncology 2008 38(2):122-128; doi:10.1093/jjco/hym161
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© The Author (2008). Published by Oxford University Press. All rights reserved
Prospective Evaluation of Selection Criteria for Active Surveillance in Japanese Patients with Stage T1cN0M0 Prostate Cancer
1 Department of Urology, Faculty of Medicine, Kagawa University, Kagawa, Japan
2 Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan
3 Department of Second Pathology, Mie University School of Medicine, Tsu, Japan
4 Department of Epidemiology and Healthcare Research, Graduated School of Medicine and Public Health, Kyoto University, Kyoto, Japan
5 Clinical Trial Coordination Office and Department of Urology, Shizuoka Cancer Center, Nagaizumi, Shizuoka, Japan
6 Clinical Trials and Practice Support Division, Center for Cancer Control and Information Services and Department of Urology, National Cancer Center, Tokyo, Japan
7 Department of Urology, Tokyo Kosei Nenkin Hospital, Tokyo, Japan
8 Department of Urology, Chiba University Graduate School of Medicine, Chiba, Japan
9 Department of Urology, Hokkaido University Graduate School of Medicine, Sapporo, Japan
10 Department of Urology, The Jikei University School of Medicine, Tokyo, Japan
11 Department of Urology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan
12 Department of Urology, Osaka Medical Center for Cancer and Cardiovascular Disease, Osaka, Japan
13 Department of Urology, Shikoku Cancer Center, Ehime, Japan
14 Department of Urology, National Cancer Center Hospital East, Chiba, Japan
15 Department of Urology, Gunma Cancer Center, Gunma, Japan
16 Department of Urology, Tohoku University Graduate School of Medicine, Miyagi, Japan
17 Department of Urology, Kurashiki Central Hospital, Okayama, Japan
18 Department of Urology, Akita University School of Medicine, Akita, Japan
19 Department of Urology, National Cancer Center Central Hospital Tokyo, Japan
20 Department of Urology, Shizuoka Cancer Center, Shizuoka, Japan
For reprints and all correspondence: Yoshiyuki Kakehi, Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan. E-mail: kakehi{at}med.kagawa-u.ac.jp
Received August 22, 2007; accepted November 18, 2007
Objective: Selection criteria for active surveillance (AS) program of localized prostate cancer remain to be standardized. The purpose was to evaluate the validity of selection criteria and investigate the feasibility of this AS program.
Methods: Patients meeting the criteria (i) stage T1cN0M0, (ii) age 50–80, (iii) serum prostate-specific antigen (PSA) 
20 ng/ml, (iv) one or two positive cores per 6–12 systematic biopsy cores, (v) Gleason score 6, and (vi) cancer involvement in positive core 50% were enrolled and encouraged to start AS for at least 6 months during the period between January 2002 and December 2003. PSA was measured bimonthly for 6 months and every 3 months thereafter. Trigger of treatment recommendation was PSA-doubling time (PSADT) of 2 years or pathological progression at re-biopsy. Primary endpoint was ‘%PSADT > 2y’, which was defined as the proportion of patients who showed PSADT assessed at 6 months >2 years out of all the patients who chose AS. Point estimate of ‘%PSADT > 2y’ was expected to be >80%.
Results: One hundred and eighteen patients opted for AS and 16 chose immediate treatment at enrollment. PSADT for the initial 6 months based on four measurements could be assessed in 106 patients. Intent-to-treat analysis of ‘%PSADT > 2y’ was 71.2% (84/118, 95% CI: 62.1–79.2). Pathological progression rate at 1-year re-biopsy was 33%. Fifty-four (46%) patients remained on AS for maximal observation of 54 months. General health-related QOL in patients undergoing AS was not impaired.
Conclusions: The primary endpoint, ‘%PSADT > 2y’, did not meet the pre-specified decision criteria. Further prospective study with revised program and endpoint is needed.
Key Words: active surveillance • prostate cancer • PSA-doubling time