Abstract：
BACKGROUND: Active surveillance for prostate cancer was initiated in the early 2000s. We assessed the long-term outcomes of active surveillance in Japan.
METHODS: This multicenter prospective observational cohort study enrolled men aged 50-80 years with stage cT1cN0M0 prostate cancer in 2002 and 2003. The eligibility criteria included serum prostate-specific antigen level ≤ 20 ng/mL, ≤ 2 positive cores per 6-12 biopsy samples, Gleason score ≤ 6, and cancer involvement < 50% in the positive core. Patients were encouraged to undergo active surveillance. Prostate-specific antigen levels were measured bimonthly for 6 months and every 3 months thereafter. Triggers for recommending treatment were prostate-specific antigen doubling time of < 2 years and pathological progression on repeat biopsy.
RESULTS: Among 134 patients, 118 underwent active surveillance. The median age, prostate-specific antigen level at diagnosis, and maximum cancer occupancy were 70 years, 6.5 ng/mL, and 11.2%, respectively. Ninety-one patients had only one positive cancer core. The median observation period was 10.7 years. At 1 year, 65.7% underwent a repeat biopsy, and 37% of patients experienced pathological progression. The active surveillance continuation rates at 5, 10, and 15 years were 28%, 9%, and 4%, respectively. One prostate cancer-related death occurred in a patient who refused treatment despite pathological progression at the one-year repeat biopsy.
CONCLUSIONS: Active surveillance according to this study protocol was associated with conversion to the next treatment without delay, when indicated, despite the selection criteria and follow-up protocols being less rigorous than those recommended in current international guidelines.
METHODS: This multicenter prospective observational cohort study enrolled men aged 50-80 years with stage cT1cN0M0 prostate cancer in 2002 and 2003. The eligibility criteria included serum prostate-specific antigen level ≤ 20 ng/mL, ≤ 2 positive cores per 6-12 biopsy samples, Gleason score ≤ 6, and cancer involvement < 50% in the positive core. Patients were encouraged to undergo active surveillance. Prostate-specific antigen levels were measured bimonthly for 6 months and every 3 months thereafter. Triggers for recommending treatment were prostate-specific antigen doubling time of < 2 years and pathological progression on repeat biopsy.
RESULTS: Among 134 patients, 118 underwent active surveillance. The median age, prostate-specific antigen level at diagnosis, and maximum cancer occupancy were 70 years, 6.5 ng/mL, and 11.2%, respectively. Ninety-one patients had only one positive cancer core. The median observation period was 10.7 years. At 1 year, 65.7% underwent a repeat biopsy, and 37% of patients experienced pathological progression. The active surveillance continuation rates at 5, 10, and 15 years were 28%, 9%, and 4%, respectively. One prostate cancer-related death occurred in a patient who refused treatment despite pathological progression at the one-year repeat biopsy.
CONCLUSIONS: Active surveillance according to this study protocol was associated with conversion to the next treatment without delay, when indicated, despite the selection criteria and follow-up protocols being less rigorous than those recommended in current international guidelines.
摘要：
背景：前列腺癌的主动监测始于2000年代初。我们评估了日本积极监测的长期结果。
方法：这项多中心前瞻性观察队列研究在2002年和2003年纳入了50-80岁cT1cN0M0期前列腺癌的男性。合格标准包括血清前列腺特异性抗原水平≤20ng/mL，每6-12个活检样本≤2个阳性核心，Gleason评分≤6分，阳性核心癌症受累<50%。鼓励患者进行主动监测。每6个月和此后每3个月测量一次前列腺特异性抗原水平。推荐治疗的触发因素是前列腺特异性抗原倍增时间<2年，重复活检病理进展。
结果：在134名患者中，118人进行了主动监视。年龄中位数,诊断时的前列腺特异性抗原水平，最大的癌症占有率是70年，6.5ng/mL,和11.2%，分别。91名患者只有一个癌症核心阳性。中位观察期为10.7年。在1年,65.7％接受了重复活检，37%的患者出现病理性进展。5年、10年和15年的主动监测持续率为28%，9%,4%,分别。1例前列腺癌相关的死亡发生在患者中，尽管在一年重复活检时病理进展，但患者拒绝治疗。
结论：根据本研究方案进行的主动监测与无延迟地转换到下一次治疗相关，当指示时，尽管选择标准和后续协议不如当前国际准则中建议的严格。
方法：这项多中心前瞻性观察队列研究在2002年和2003年纳入了50-80岁cT1cN0M0期前列腺癌的男性。合格标准包括血清前列腺特异性抗原水平≤20ng/mL，每6-12个活检样本≤2个阳性核心，Gleason评分≤6分，阳性核心癌症受累<50%。鼓励患者进行主动监测。每6个月和此后每3个月测量一次前列腺特异性抗原水平。推荐治疗的触发因素是前列腺特异性抗原倍增时间<2年，重复活检病理进展。
结果：在134名患者中，118人进行了主动监视。年龄中位数,诊断时的前列腺特异性抗原水平，最大的癌症占有率是70年，6.5ng/mL,和11.2%，分别。91名患者只有一个癌症核心阳性。中位观察期为10.7年。在1年,65.7％接受了重复活检，37%的患者出现病理性进展。5年、10年和15年的主动监测持续率为28%，9%,4%,分别。1例前列腺癌相关的死亡发生在患者中，尽管在一年重复活检时病理进展，但患者拒绝治疗。
结论：根据本研究方案进行的主动监测与无延迟地转换到下一次治疗相关，当指示时，尽管选择标准和后续协议不如当前国际准则中建议的严格。
