Long-term followup of a randomized trial of 0 versus 3 months of neoadjuvant androgen ablation before radical prostatectomy
Long-term followup of a randomized trial of 0 versus 3 months of neoadjuvant androgen ablation before radical prostatectomy
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DOI：
10.1097/01.ju.0000081404.98273.fd
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发表时间：
2003-09-01
影响因子：
6.6
通讯作者：
Chatterjee, S
中科院分区：
文献类型：
--
作者：
Klotz, LH;Goldenberg, SL;Chatterjee, S
目的：1992 年，我们发起了一项全国随机前瞻性试验，对根治性前列腺切除术前使用醋酸环丙孕酮 3 个月与单纯前列腺切除术进行比较。初步结果表明，手术切缘阳性率下降了 50%。这种下降并未转化为 3 年前列腺特异性抗原 (PSA) 进展的差异。本报告是关于该队列的长期结果（中位随访 6 年）。 材料和方法：这项前瞻性、随机、开放标签试验将手术前 100 毫克醋酸环丙孕酮每天 3 次、持续 3 个月与单独手术进行了比较。随机化发生在1993年1月至1994年4月之间。根据临床分期、基线血清PSA和格里森总和对患者进行分层。共有 213 名患者入院。生化进展定义为间隔至少 4 周连续 2 次检测到 PSA（大于 0.2 ng/ml）、重新治疗或死于前列腺癌。 结果：在中位随访 6 年期间，总共 34 名（33.6%）只接受手术的患者和 42 名（37.5%）接受新辅助激素治疗 (NHT) 的患者出现生化复发。尽管本研究中病理分期显着下降，但无生化疾病 (bNED) 生存证据的患者数量没有显着差异 (p = 0.732)。在基线 PSA 大于 20 的男性中，bNED 生存获益有利于 NHT（p = 0.015）。结论：经过 6 年的随访，3 个月的 NHT 没有带来总体获益。在最高风险 PSA 组（PSA 大于 20）中，bNED 生存率有所改善。高风险患者可能从 NHT 中受益的可能性值得进一步调查。
Purpose: In 1992 we initiated a national randomized prospective trial of 3 months of cyproterone acetate before radical prostatectomy compared to prostatectomy alone. Initial results indicated a 50% decrease in the rate of positive surgical margins. This decrease did not translate into a difference in prostate specific antigen (PSA) progression at 3 years. This report is on the long-term outcome (median follow up 6 years) of this cohort.Materials and Methods: This prospective, randomized, open label trial compared 100 mg cyproterone acetate 3 times daily for 3 months before surgery to surgery alone. Randomization occurred between January 1993 and April 1994. Patients were stratified according to clinical stage, baseline serum PSA and Gleason sum. A total of 213 patients were accrued. Biochemical progression was defined as 2 consecutive detectable PSAs (greater than 0.2 ng/ml) at least 4 weeks apart, re-treatment or death from prostate cancer.Results: A total of 34 (33.6%) patients undergoing surgery only and 42 (37.5%) patients given neoadjuvant hormone therapy (NHT) had biochemical recurrence during the median follow up of 6 years. Despite the significant pathological down staging in this study, there was no significant difference in number of patients with no evidence of biochemical disease (bNED) survival (p = 0.732). A bNED survival benefit favoring NHT was seen in men with a baseline PSA greater than 20 (p = 0.015).Conclusions: After 6 years of follow up there was no overall benefit with 3 months of NHT. Improved bNED survival was seen in the highest risk PSA group (PSA greater than 20). The possibility that high risk patients may benefit from NHT warrants further investigation.