Kakehi Yoshiyuki, Kamoto Toshiyuki, Shiraishi Taizou, Ogawa Osamu, Suzukamo Yoshimi, Fukuhara Shunichi, Saito Yuko, Tobisu Ken-Ichi, Kakizoe Tadao, Shibata Taro, Fukuda Haruhiko, Akakura Koichiro, Suzuki Hiroyoshi, Shinohara Nobuo, Egawa Shin, Irie Akira, Sato Takefumi, Maeda Osamu, Meguro Norio, Sumiyoshi Yoshiteru, Suzuki Takanori, Shimizu Nobuaki, Arai Yoichi, Terai Akito, Kato Tetsuro, Habuchi Tomonori, Fujimoto Hiroyuki, Niwakawa Masashi
Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan.
Jpn J Clin Oncol. 2008 Feb;38(2):122-8. doi: 10.1093/jjco/hym161. Epub 2008 Feb 12.
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.
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%.
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.
The primary endpoint, '%PSADT > 2y', did not meet the pre-specified decision criteria. Further prospective study with revised program and endpoint is needed.
局限性前列腺癌主动监测（AS）项目的选择标准仍有待规范。本研究旨在评估选择标准的有效性，并探讨该AS项目的可行性。
纳入符合以下标准的患者：（i）T1cN0M0期；（ii）年龄50 - 80岁；（iii）血清前列腺特异性抗原（PSA）≤20 ng/ml；（iv）每6 - 12个系统活检核心中有1个或2个阳性核心；（v）Gleason评分≤6；（vi）阳性核心中的癌灶累及≤50%。在2002年1月至2003年12月期间，鼓励这些患者开始至少6个月的AS。在6个月内每两个月测量一次PSA，之后每3个月测量一次。治疗推荐的触发因素为PSA倍增时间（PSADT）≤2年或再次活检时病理进展。主要终点为“%PSADT > 2年”，定义为选择AS的所有患者中，6个月时评估的PSADT > 2年的患者比例。预计“%PSADT > 2年”的点估计值>80%。
118例患者选择AS，16例在入组时选择立即治疗。基于四次测量的最初6个月的PSADT可在106例患者中进行评估。“%PSADT > 2年”的意向性分析为71.2%（84/118，95%CI：62.1 - 79.2）。1年再次活检时的病理进展率为33%。54例（46%）患者继续接受AS，最长观察54个月。接受AS的患者总体健康相关生活质量未受损害。
主要终点“%PSADT > 2年”未达到预先设定的决策标准。需要采用修订后的方案和终点进行进一步的前瞻性研究。
